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Pre-filled Syringe

by Hangzhou Primecare Medical Co., Ltd. 7 variants

Ref 01/01/99/KB/10/GHC, 09/10/10/GLY, PCAA02, 30405010, 10000028

Active European Union and United States

CE MDR 510(k)

Valid until

Not listed

CE: no date in EUDAMED. FDA: not time-limited

FDA recalls

None found

in data synced 24 Oct 2026

Documents

None linked in EUDAMED

A group certificate may exist

510(k) K202698↗

FDA record

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source EUDAMED, FDA 510(k), synced 24 Oct 2026. What this means

Regulatory status

as of registry sync 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number697236069PS04MD Basic UDI-DI Date8 Dec 2025RegisteredStatusActive
United StatesFDA 510(k) 510(k) NumberK202698 Date15 Dec 2020IssuedStatusActive

Certificates

0 certificates · EUDAMED

EUDAMED lists no certificate for this device's Basic UDI-DI.

A certificate issued for a device group may exist without being linked here.

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 24 Oct 2026.

Coverage

2 jurisdictions

United States of AmericaSwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered
  • United States FDA 510(k) Active
  • European Union CE/MDR Active

Specification

EUDAMED · 510(k)

Model / Reference
01/01/99/KB/10/GHC, 09/10/10/GLY, PCAA02, 30405010, 10000028
Primary DI / UDI-DI
06972360695643, 06972360695650, 06972360691713, 06972360695612, 06972360695841, 06972360693779, 06972360692505, 46972360695900, 06972360695629, 06972360695438
Basic UDI-DI
697236069PS04MD, 697236069PS01M7
EMDN Code
A02010799, A02010702
Device Class
Class I
EU market of registration
Germany
Czechia

Manufacturer details

EUDAMED SRN
CN-MF-000011403
Authorised representative
MedPath GmbH DE-AR-000000087

Other devices from Hangzhou Primecare Medical Co., Ltd.

See all devices from Hangzhou Primecare Medical Co., Ltd. →

Properties

  • Sterile

Other properties (12)

  • Implantable: No
  • Reusable: No
  • Contains Latex: No
  • Reprocessed: No
  • CMR Substance: No
  • Human-derived: No
  • Human Tissues: No
  • Animal Tissues: No
  • Endocrine Disruptor: No
  • Administering Medicine: No
  • Measuring Function: No
  • Incorporates Medicinal Product: No