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Disposable vaginal speculum

by Yuhuan City Shengbo Mould Manufacturing Co., Ltd. 5 variants

Ref SY001A-SModel S

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

CE MDD

Valid until

Not listed

EUDAMED holds no validity date

FDA recalls

Not checked

No FDA submission to match recalls against

Documents

None linked in EUDAMED

A group certificate may exist

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source EUDAMED, GUDID, synced 24 Oct 2026. What this means

Regulatory status

as of registry sync 24 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing GUDID Number26972903331124 UDI-DI Date11 May 2025ListedStatusListed GUDID: in commercial distribution
European UnionCE/MDD EUDAMED NumberB-26972903331124 Basic UDI-DI Date21 Mar 2025RegisteredStatusActive

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.

Coverage

2 jurisdictions

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  • Withdrawn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

Specification

EUDAMED · GUDID

Trade Name
Shengbo
Generic Name
Vaginal speculum, single-use
Device Name
Disposable vaginal speculum
Model / Reference
S EUDAMED
SY001A-S EUDAMED
8112 GUDID
Primary DI / UDI-DI
26972903331124, 06972903331120
Basic UDI-DI
B-26972903331124, B-06972903331120
FDA Product Code
HIB
EMDN Code
U089006 Vaginal speculum, single-use
GMDN Term
Vaginal speculum, single-use
Device Class
Class I EUDAMED
Class II GUDID
Regulation Number
884.4530
EU market of registration
France
GUDID distribution status
In Commercial Distribution

Truth per registry

2 sources · 3 fields differ

FieldEUDAMEDGUDID
Model / ReferenceEUDAMED
S
SY001A-S
GUDID
8112
Device ClassEUDAMED
Class I
GUDID
Class II
SterileEUDAMED
Yes
GUDID
No

Manufacturer details

EUDAMED SRN
CN-MF-000036867
Authorised representative
Prolinx GmbH DE-AR-000005129

Other devices from Yuhuan City Shengbo Mould Manufacturing Co., Ltd.

See all devices from Yuhuan City Shengbo Mould Manufacturing Co., Ltd. →

Properties

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

Other properties (17)

  • Implantable: No
  • Reusable: No
  • Contains Latex: No
  • Reprocessed: No
  • Human-derived: No
  • Human Tissues: No
  • Animal Tissues: 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