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Ultraspec Screening Speculum Small w/o Ratchet
EUDAMEDClass I (EU MDR)
Ref 9125Ref 9124
Identity
- Trade Name
- Ultraspec Screening Speculum Small w/o Ratchet EUDAMED
- Device Name
- Non sterile speculums EUDAMED
- Model / Reference
- 9125 EUDAMED9124 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 05010058091252 EUDAMED05010058091245 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 Small w/o Ratchet 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 (2)
- EUDAMED 5c4d42c1-dca1-4685-9fe6-8b11f65185dc 61 fields · synced Oct 6, 2026
- EUDAMED fea2e1d9-d267-4b71-8c78-624f9fc6a1e8 61 fields · synced May 19, 2026