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Sterile Insulin Syringes with needles for single use

by Shandong Caremed Medical Products Co., Ltd. 2 variants

Ref 0.5mL, 1mL, 0.3mLModel 0.3mL,0.5mL,1mL

Active European Union. Also listed in GUDID (US).

CE MDR

Valid until

Not listed

EUDAMED holds no validity date

FDA recalls

None found

in data synced 22 Oct 2026

Documents

None linked in EUDAMED

A group certificate may exist

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source EUDAMED, GUDID, synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing GUDID Number16976523540242 UDI-DI Date26 Aug 2026ListedStatusListed GUDID: in commercial distribution
European UnionCE/MDR EUDAMED Number697652354YDS001QU Basic UDI-DI Date2 Aug 2024RegisteredStatusActive

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 22 Oct 2026.

Coverage

2 jurisdictions

United States of AmericaSwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered
  • European Union CE/MDR Active
  • United States GUDID listing Listed

Specification

EUDAMED · GUDID

Generic Name
Insulin syringe/needle, basic
Model / Reference
0.3mL, 0.5mL, 1mL
Primary DI / UDI-DI
16976523540242, 06976523540245, 06976523540252, 16976523540235
Basic UDI-DI
697652354YDS001QU
510(k) Number
FDA Product Code
FMF
EMDN Code
A02010699 Insulin syringes, single-use - other
GMDN Term
Insulin syringe/needle, basic
Device Class
Class IIa EUDAMED
Class II GUDID
Regulation Number
880.5860
EU market of registration
Austria
GUDID distribution status
In Commercial Distribution

Truth per registry

2 sources · 1 field differs

FieldEUDAMEDGUDID
Device ClassEUDAMED
Class IIa
GUDID
Class II

Manufacturer details

EUDAMED SRN
CN-MF-000033413
Authorised representative
Lotus NL B.V. NL-AR-000000121

Other devices from Shandong Caremed Medical Products Co., Ltd

See all devices from Shandong Caremed Medical Products Co., Ltd →

Properties

  • Sterile
  • Single Use
  • Lot / Batch Number
  • Serial Number
  • Expiration Date
  • Manufacturing Date

Other properties (18)

  • 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
  • Prescription Use: No
  • Over-the-Counter: No
  • Convenience Kit: No
  • Combination Product: No
  • HCT/P: No
  • Premarket Exempt: No