Identity
- Trade Name
- Speculas EUDAMED
- Device Name
- Cusco Vaginal Speculum 75x17mm virgin EUDAMED
- Model / Reference
- 60001401 EUDAMED
Identifiers
- Primary DI / UDI-DI
- G11360001401 EUDAMED
- Basic UDI-DI
- ++G113600014019D EUDAMED
- EMDN Code
- L149004 ENT SPECULUMS, REUSABLE EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Germany 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
Speculas by Hilbro Instruments (pvt) 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 | ++G113600014019D | Class I | Active |
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Manufacturer
- Manufacturer
- Hilbro Instruments (pvt) Ltd
- EUDAMED SRN
- PK-MF-000023402
- Authorised Representative
- ANTEX MEDI SOLUTION DE-AR-000008078
Sources (1)
- EUDAMED e160d810-c022-444d-95ac-e0c7ae5b2055 61 fields · synced Jul 17, 2026