Identity
- Device Name
- Speculums EUDAMED
- Model / Reference
- B001510.35 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08961102857782 EUDAMED
- Basic UDI-DI
- 896110285Speculums4D EUDAMED
- Direct Marketing DI
- 08961102857782 EUDAMED
- EMDN Code
- L059001 VAGINAL SPECULUMS, REUSABLE EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Netherlands EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Implantable
No
EUDAMED
Reusable
No
EUDAMED
Contains Latex
No
EUDAMED
Reprocessed
No
EUDAMED
CMR Substance
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Endocrine Disruptor
No
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
Speculums by Expert International — Class I — MDR — listed in EUDAMED — regulatory data on deviCERTS
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/MDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 896110285Speculums4D | Class I | Active |
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Manufacturer
- Manufacturer
- Expert International
- EUDAMED SRN
- PK-MF-000019078
- Authorised Representative
- KHANG BAO INTERNATIONAL KFT HU-AR-000034102
Sources (1)
- EUDAMED a8aa636a-0b8a-4721-96ae-d6a1796ae199 61 fields · synced Jul 21, 2026