Shanghai Berry Electronic Tech Co., Ltd.
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.
Produsen teknologi yang dapat dipakai dan perangkat pintar
Shanghai Berry Electronic Tech Co., Ltd. terdaftar di direktori resmi MEDICA atau COMPAMED 2025 dengan tag Produsen atau OEM. Profilnya berisi produk teknologi wearable yang serasi.
- Type
- manufacturer (our classification of the record, not a statement by the company)
- Role
- Manufacturer (official record)
- Location
- Shanghai, China
- Founded
- 2003 (as stated by the company, not confirmed by a state register)
- Website
- https://shberrymed.com
- Categories
- Perangkat yang Dapat Dipakai & Perangkat Pribadi
Listed in a source registry
What is established and what is not
No researcher review has been written for this company yet. 4 official records from 4 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
- 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 2026-08-09. Mail server of the company domain
- Registered with the market regulator: United States (record type: market-access-us; this record does not by itself establish manufacturing) [official record; status green] Shows the facility is on the destination market's list of establishments approved for the listed goods. A listing is not an observation of current production. checked 2026-08-23. FDA device establishment registration (openFDA, U.S. Food and Drug Administration)
- Site address listed in a government regulator's register (record type: facility-registered; this record does not by itself establish manufacturing) [official record; status green] Shows the regulator records a site of this company at a named address. A registration is not an observation of current production. checked 2026-08-07. US FDA device establishment registration (openFDA)
- product-authorised-for-sale-holder (record type: product-authorised-for-sale-holder) [official record; status green] Applicant to the US FDA for 3 medical devices: Pulse Oximeter (K250837, 2025-09-25), Pulse Oximeter (K172141, 2018-04-04), Pulse Oximeter (K142687, 2015-04-13). The applicant answers for the notification; the record does not say who makes the device. A national regulator lists this company as the holder of the registration of products it has authorised for sale in that country. The holder answers for the product on that market; the record does not say the holder makes it. effective since 2026-10-05. FDA premarket notifications 510(k) and De Novo (openFDA, U.S. Food and Drug Administration)
- 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 2026-08-09. Domain registry record
- 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. Screened by name only: no legal entity is established for this record, so this is not a clearance. checked 2026-08-09. OpenSanctions
- 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. Screened by name only: no legal entity is established for this record, so this is not a clearance. checked 2026-08-09. OpenSanctions
- 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
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
- Oximeter, Wellness: Products on the register. FDA device establishment registration (openFDA, U.S. Food and Drug Administration)
- US: Approved for this market, country US. FDA device establishment registration (openFDA, U.S. Food and Drug Administration)
Candidates, not confirmed
- shberrymed.com: Website of this business. Source record
Import rules for these goods
- Electronics for the EU need CE marking incl. RoHS substance limits, and producers must register for WEEE take-back in each member state of sale. European Commission (CE)
- Electronics for the US market need FCC equipment authorization under 47 CFR Part 15, which covers unintentional radiators such as switch-mode power supplies, not only radio devices. US FCC (Part 15)