Identity
- Trade Name
- Sterile Speculums with retractor EUDAMED
- Device Name
- Sterile Speculums with retractor EUDAMED
- Model / Reference
- 9175 EUDAMED9176 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 05010058091757 EUDAMED05010058091764 EUDAMED
- Basic UDI-DI
- 5010058CIsT046G00BSQ EUDAMED
- EMDN Code
- U089006 VAGINAL SPECULUM, SINGLE-USE EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Ireland 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
Sterile Speculums with retractor by Robinson Healthcare Ltd — 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 | 5010058CIsT046G00BSQ | Class I | Active |
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Manufacturer
- Manufacturer
- Robinson Healthcare Ltd
- EUDAMED SRN
- GB-MF-000016546
- Authorised Representative
- Advena Limited MT-AR-000000234
Sources (2)
- EUDAMED 6a7dbd7f-2e0c-4fa4-835e-fe1bc2660104 61 fields · synced Oct 6, 2026
- EUDAMED 93526bf1-b3d6-42b0-bc2f-fb3f86b37152 61 fields · synced May 17, 2026