F Care Systems N.V.
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.
巴西卫生监管机构 ANVISA 持有该工厂有效的良好生产规范证书，涵盖医疗器械（MDSAP 审核计划），有效期至 2030 年 2 月 2 日。该证书是在对工厂本身进行检查后颁发的，这就是外国监管机构命名该工厂的原因：这里生产的产品可以进入巴西市场。进程号25351209336202543。
- Type
- manufacturer (our classification of the record, not a statement by the company)
- Role
- Manufacturer (official record)
- Location
- Belgium
- Founded
- 1996 (matches the state register)
- Categories
- 医疗保健用品
- Markets
- 比利时, 巴西
Listed in a source registry
What is established and what is not
No researcher review has been written for this company yet. 10 official records from 6 official sources are on file. 2 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
- 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 2026-08-24. 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 2026-08-24. OpenSanctions
- 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 2026-08-23. GLEIF global LEI register (golden copy)
- Legally registered and still active (record type: registry-active-global) [official record; status green] Indicates the company is not dissolved or winding down. checked 2026-10-15. Crossroads Bank for Enterprises (KBO/BCE), full open-data file
- Registered for trade, not manufacturing (record type: registered-trade-only) [official record; status amber] Indicates the register lists trade, not production. checked 2026-10-15. Crossroads Bank for Enterprises (KBO/BCE), full open-data file
- manufacturing-practice-certified (record type: manufacturing-practice-certified) [official record; status green] A regulator of health products inspected this site and certified how it manufactures the product class named, for example medical devices or cosmetics. It is about manufacturing practice at the site, not a medicines licence. checked 2026-10-03. ANVISA (Brazilian Health Regulatory Agency), public register of Good Manufacturing Practice certificates (CBPF)
- Named directors on file (record type: directors-on-file) [official record; status green] 4 directors on file. The register names the people who run the company, so there is someone answerable if something goes wrong. checked 2026-10-03. Crossroads Bank for Enterprises (KBO/BCE) public search, Belgium
- Street address on file in the state register (record type: registered-address) [official record; status green] Registered address: Uitbreidingstraat 42-46, 2600 Antwerpen. The address the company itself gave the register, so post and inspectors reach it there. checked 2026-10-03. Crossroads Bank for Enterprises (KBO/BCE) public search, Belgium
- On the company register (record type: registered-since) [official record; status green] On the company register since 1996-08-30. Shows how long the company has been on the state register, which is hard to fake and easy to check. checked 2026-10-03. Crossroads Bank for Enterprises (KBO/BCE) public search, Belgium
- Workforce size in the company register (record type: workforce-on-record) [official record; status green] Tells you whether the supplier can realistically take on your volume. checked 2026-10-03. Crossroads Bank for Enterprises (KBO/BCE) public search, Belgium
- Registered as a manufacturer (record type: registered-manufacturer) [official record; status green] Its own declared activity in the register covers making these goods. checked 2026-10-03. 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
Relationships
1 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
- 4 more officer(s), not named in the record: Officer in the register. Crossroads Bank for Enterprises (KBO/BCE) public search, Belgium
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)