Identity
- Trade Name
- Pelispec Medium Long without lock EUDAMED
- Device Name
- Comfispec - Pelispec Vaginal Speculum EUDAMED
- Model / Reference
- 400102 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 05060265383183 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 Medium Long without lock 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 2ce44ea4-23a2-457e-8ffd-9551195a6272 61 fields · synced Jun 17, 2026