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Speculum, vaginal, Sims, retractor, double-ended, large
EUDAMEDClass I (EU MDR)
Ref 16-125-00
Identity
- Device Name
- Speculum, vaginal, Sims, retractor, double-ended, large EUDAMED
- Model / Reference
- 16-125-00 EUDAMED
Identifiers
- Primary DI / UDI-DI
- +G198161250004 EUDAMED
- Basic UDI-DI
- ++G198Speculum59 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
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
Category: Vaginal speculum, reusable
Speculum, vaginal, Sims, retractor, double-ended, large by Durable Hospital Supplies — Class I — MDR — listed in EUDAMED — regulatory data on deviCERTS
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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 | ++G198Speculum59 | 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 bd980f27-a76f-4f84-ba4a-46ad4881deaf 61 fields · synced Jul 9, 2026