Identity
- Trade Name
- SHENGBO FDA UDI
- Generic Name
- Vaginal speculum, single-use FDA UDI
- Device Name
- Disposable vaginal speculum EUDAMEDDisposable Vaginal Speculum Small FDA UDI
- Model / Reference
- M EUDAMEDSY002-M EUDAMED8121 FDA UDI
- Description
- Disposable Vaginal Speculum Small FDA UDI
Identifiers
- Primary DI / UDI-DI
- 06972903331212 EUDAMEDFDA UDI
- Basic UDI-DI
- B-06972903331212 EUDAMED
- FDA Product Code
- HIB FDA UDI
- EMDN Code
- U089006 VAGINAL SPECULUM, SINGLE-USE EUDAMED
- GMDN Term
- Vaginal speculum, single-use FDA UDI
Classification
- Device Class
- Class I EUDAMEDClass II FDA UDI
- Regulation Number
- 884.4530 FDA UDI
- Market of Registration
- Poland EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
EUDAMEDFDA UDI
Single Use
Yes
FDA UDI
Implantable
No
EUDAMEDFDA UDI
Reusable
No
EUDAMED
Contains Latex
No
EUDAMEDFDA UDI
Reprocessed
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
Prescription Use
No
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
Yes
FDA UDI
Lot / Batch Number
No
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
Yes
FDA UDI
Disposable vaginal speculum by Yuhuan City Shengbo Mould Manufacturing Co., Ltd. — Class I — MDD, FDA UDI — listed in EUDAMED, FDA GUDID
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Active
CE/MDD
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDD | B-06972903331212 | Class I | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- Yuhuan City Shengbo Mould Manufacturing Co., Ltd.
- EUDAMED SRN
- CN-MF-000036867
- Authorised Representative
- Prolinx GmbH DE-AR-000005129
Sources (2)
- EUDAMED 1c9e5bb8-7d2f-4fcc-9afc-d139444e6a6a 61 fields · synced Oct 7, 2026
- FDA UDI 77150fb6-f2db-4d0e-9722-1843e883e32d 33 fields · synced May 30, 2026