Identity
- Device Name
- Retractor, vaginal, Doyen, 8.5 x 4.5cm EUDAMED
- Model / Reference
- 16-178-23 EUDAMED
Identifiers
- Primary DI / UDI-DI
- +G19816178230H EUDAMED
- Basic UDI-DI
- B-+G19816178230H EUDAMED
- EMDN Code
- L059001 VAGINAL SPECULUMS, REUSABLE EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Italy EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Implantable
No
EUDAMED
Reusable
Yes
EUDAMED
Contains Latex
No
EUDAMED
Reprocessed
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
Category: Vaginal speculum, reusable
Retractor, vaginal, Doyen, 8.5 x 4.5cm by Durable Hospital Supplies — Class I — MDD — listed in EUDAMED — regulatory data on deviCERTS
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Also classified as Vaginal speculum, reusable.
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Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/MDD
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDD | B-+G19816178230H | Class I | Active |
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Manufacturer
- Manufacturer
- Durable Hospital Supplies
- EUDAMED SRN
- PK-MF-000025646
- Authorised Representative
- CMC Medical Devices & Drugs SL ES-AR-000000293
Sources (1)
- EUDAMED 178b99c6-ea09-4a4e-acdf-40a2fb7cb6fe 61 fields · synced Jul 9, 2026