TestLine Clinical Diagnostics s.r.o.
Company-provided description, not an official-source fact. Certifications, capacities, years and market positions stated in it are the company's own claims until a record below confirms them.
人間および動物用の臨床検査用診断薬の開発、製造、販売 |テ
TestLine Clinical Diagnostics s.r.o. - 人間および動物用の臨床検査用診断薬の開発、製造、販売
- Type
- manufacturer (our classification of the record, not a statement by the company)
- Role
- Manufacturer (official record)
- Location
- Brno, Czechia
- Current legal entity registered
- 1993-04-21 (state register record of the current legal entity)
- Website
- https://testlinecd.com
- Categories
- 医療およびヘルスケア用品
Listed in a source registry
What is established and what is not
No researcher review has been written for this company yet. 11 official records from 7 official sources are on file. 4 other entries are not official records: our own technical checks and searches, open directory listings, our inferences or the company's own statements. Everything is listed below with its evidence type: each entry confirms only what it literally says; none of them is a review. The manufacturing role above rests on the official records listed below, and only as far as each literally goes: a facility registration or licence is not an observation of current production. Nothing here confirms ownership or trading status beyond what each record literally says.
Facts on file, each with its evidence type
- Website domain registered (record type: domain-registered) [our own observation, not an official record; status green] Shows how long this web address has been registered. That is the age of the domain, not of the company: a domain can change owners. checked 2026-08-23. Domain registry record
- No match found in the debarment registers we checked (record type: debarment-clear) [our own observation, not an official record; name search, no matching candidate] We searched the public debarment datasets and found no matching candidate. Absence from these lists is a search result, not a certificate. checked 2026-08-23. OpenSanctions
- No match found on the sanctions lists we checked (record type: sanctions-clear) [our own observation, not an official record; name search, no matching candidate] We searched the public sanctions datasets and found no matching candidate. A name search is not full compliance screening. checked 2026-08-23. OpenSanctions
- Business email on the company's own domain (record type: corporate-mail-on-domain) [our own observation, not an official record; status green] Shows the domain runs its own email rather than a free mailbox. It describes the domain, not who owns it. checked 2026-08-23. Mail server of the company domain
- registry-activity (record type: registry-activity) [official record; status green] Activity code in the state register: NACE 32500. Shows what the state itself says the company does, which you can compare with what it promises you. effective since 1993-04-21. ARES (Czech business register)
- Directors named in the company register (record type: leadership-on-record) [official record; status green] Registry lists 2 officers: MICHAL BERÁNEK, MICHAL KOSTKA Matched to this company by name only; no second anchor confirms it is the same legal entity.. The people leading the company are named in a public record. effective since 2020-01-16. ARES (Czech business register)
- Active legal entity ID (LEI) (record type: lei-active) [official record; status green] A global identifier used in finance; an active one is renewed yearly. checked 2026-09-07. GLEIF global LEI register (golden copy)
- Legally registered and still active (record type: registry-active-global) [official record; status green] Shows the register lists the registration as active on the date we read it. It does not show how busy the business is. checked 2026-08-24. ARES (Czech business register)
- Market access approved: European Union (record type: market-access-eu) [official record; status green] Shows the establishment is approved for the listed activities under the EU food-hygiene rules and appears in the EU list of approved establishments. It is not an import check and not an observation of current production. checked 2026-08-22. TRACES NT, European Commission register of approved establishments (DG SANTE)
- Workforce size in the company register (record type: workforce-on-record) [official record; status green] Between 250 and 499 employees on the state record. One indication of the company's size as the register records it; it does not establish production capacity. checked 2026-10-16. ARES, registr ekonomických subjektů (Česká republika)
- Takes part in public tenders (record type: public-contract-awarded) [official record; status green] 37 public contracts on record, the latest awarded 2026-09-21. A public buyer selected this supplier through an official tender. Open the source for the contracts themselves. effective since 2026-09-21. TED (Tenders Electronic Daily), EU public procurement award notices ここでの落札は、他者による審査も伴います。EUおよびEEAでは、公共調達者は詐欺、汚職、資金洗浄で有罪となった入札者、および確定した決定で税や社会保険料の未納が認定された入札者を排除しなければなりません。 この審査はその入札の落札日時点のものです。会社の現在の状況を示すものではなく、落札は契約が履行されたことを示すものでもありません。 Directive 2014/24/EU, Article 57 (exclusion grounds)
- Named directors on file (record type: directors-on-file) [official record; status green] 2 directors on file Matched to this company by name only; no second anchor confirms it is the same legal entity.. The register names the people who run the company, so there is someone answerable if something goes wrong. checked 2026-10-20. ARES (Czech business register)
- Registered as a manufacturer (record type: registered-manufacturer) [official record; status green] Its own declared activity in the register covers making these goods. checked 2026-10-17. ALIMS (Medicines and Medical Devices Agency of Serbia), register of medical-device manufacturers
- Registry ID checks out with the state register (record type: registry-id-verified) [official record; status green] Helps confirm the company on this page is the same legal entity as in the register. checked 2026-09-10. GLEIF Global LEI record
- On the company register (record type: registered-since) [official record; status green] On the company register since 1993-04-21. Shows how long the company has been on the state register, which is hard to fake and easy to check. effective since 1993-04-21. ARES (Czech business register)
Relationships
4 relationship(s) on file. Each line names the other party, the relationship as its source records it, and the source. A record of a relationship is not a finding about control beyond what it literally says.
Recorded in a source
- MICHAL BERÁNEK: Officer in the register. ARES (Czech business register)
- MICHAL KOSTKA: Officer in the register. ARES (Czech business register)
- Křižíkova 188/68, 612 00 Brno, 602 00, Brno: Holds the site's permit, registry number CZ 62712671. TRACES NT, European Commission register of approved establishments (DG SANTE)
Candidates, not confirmed
- testlinecd.com: Website of this business. Source record
Import rules for these goods
- Medical devices sold in the EU must carry CE marking under the Medical Device Regulation (EU) 2017/745, with a conformity assessment matched to the device risk class. European Commission (MDR)
- For the US market, the maker must have an FDA device establishment registration and product listing; most instruments also need 510(k) premarket clearance. US FDA (devices)