Identity
- Trade Name
- Pelispec Sims Large EUDAMED
- Device Name
- Comfispec - Pelispec Vaginal Speculum EUDAMED
- Model / Reference
- 400135 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 05060265383237 EUDAMED
- Basic UDI-DI
- 50602653837468LE EUDAMED
- EMDN Code
- U089006 VAGINAL SPECULUM, SINGLE-USE EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Ireland EUDAMED
Clinical & Handling
Sterile
Yes
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
Pelispec Sims Large by Williams Medical Supplies 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 | 50602653837468LE | Class I | Active |
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Manufacturer
- Manufacturer
- Williams Medical Supplies Ltd
- EUDAMED SRN
- GB-MF-000024120
- Authorised Representative
- Fannin Ltd. IE-AR-000002249
Sources (1)
- EUDAMED 7d30c6ad-17ac-4abd-89ce-6b97f06ede75 61 fields · synced Jul 8, 2026