Identity
- Trade Name
- Ultraspec Screening Speculum Broad EUDAMED
- Device Name
- Non sterile speculums EUDAMED
- Model / Reference
- 9138 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 05010058091382 EUDAMED
- Basic UDI-DI
- 5010058CInT047G00APE 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
Ultraspec Screening Speculum Broad 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 | 5010058CInT047G00APE | 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 (1)
- EUDAMED b234cae5-c5c0-47f1-b674-f3c6c31d76f8 61 fields · synced Jun 20, 2026