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Disposable Nitrile Gloves

by Shanghai chongjen industry co., ltd 11 variants

Ref M

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

CE MDR

Valid until

Not listed

EUDAMED holds no validity date

FDA recalls

Not checked

No FDA submission to match recalls against

Documents

None, self-declared

Class I: no certifier involved

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
European UnionCE/MDR EUDAMED Number697468169Nitrile-Glove5V Basic UDI-DI 06974681690314UDI-DIDate15 Dec 2025RegisteredStatusActive
United StatesGUDID listing GUDID Number06974681690314 UDI-DI Date17 Jan 2023ListedStatusListed GUDID: in commercial distribution

Certificates

0 certificates · EUDAMED

No certifier certificate is listed. Devices of this class are self-declared by the manufacturer.

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  • Withdrawn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

Trade Name
Chongjen
Generic Name
Surgical cap, single-use
Device Name
Disposable Nitrile Gloves
Model / Reference
M EUDAMED
Mesh Cap GUDID
21" GUDID
Primary DI / UDI-DI
06974681690314
Basic UDI-DI
697468169Nitrile-Glove5V
FDA Product Code
FYF
EMDN Code
T01020204 Nitrile examination / treatment gloves
GMDN Term
Surgical cap, single-use
Device Class
Class I
Regulation Number
878.4040
EU market of registration
Germany
GUDID distribution status
In Commercial Distribution

Truth per registry

2 sources · 1 field differs

FieldEUDAMEDGUDID
Model / ReferenceEUDAMED
M
GUDID
Mesh Cap,21"

Manufacturer details

EUDAMED SRN
CN-MF-000009780
Authorised representative
SUNGO Europe B.V. NL-AR-000000247

Other devices from Shanghai chongjen industry co., ltd

See all devices from Shanghai chongjen industry co., ltd →

Properties

  • Single Use
  • Premarket Exempt
  • Lot / Batch Number

Other properties (21)

  • Sterile: No
  • 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
  • Serial Number: No
  • Expiration Date: No
  • Manufacturing Date: No