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Cervical Specimen Collection Kit

by Jiangsu Yimi Bio-Tech Co., Ltd

Ref SC1

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 Number697483797CSCK0013P Basic UDI-DI 06974837970017UDI-DIDate3 Aug 2023RegisteredStatusActive
United StatesGUDID listing GUDID Number06974837970017 UDI-DI Date1 Feb 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  • Withdrawn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
GenoLocker
Generic Name
Oral/upper respiratory tract specimen collection kit IVD, clinical
Device Name
Cervical Specimen Collection Kit
Model / Reference
SC1 EUDAMED
YMSA-1D GUDID
Primary DI / UDI-DI
06974837970017
Basic UDI-DI
697483797CSCK0013P
FDA Product Code
FMH
EMDN Code
U0899 Gynaecological devices - other
GMDN Term
Oral/upper respiratory tract specimen collection kit IVD, clinical
Device Class
Class I
Regulation Number
864.3250
EU market of registration
Austria
GUDID distribution status
In Commercial Distribution

Truth per registry

2 sources · 1 field differs

FieldEUDAMEDGUDID
Model / ReferenceEUDAMED
SC1
GUDID
YMSA-1D

Manufacturer details

EUDAMED SRN
CN-MF-000011498
Authorised representative
SUNGO Europe B.V. NL-AR-000000247

Properties

  • Single Use
  • Premarket Exempt
  • Expiration Date
  • Manufacturing Date

Other properties (20)

  • 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
  • Lot / Batch Number: No
  • Serial Number: No