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Collin speculum 85x30mm
EUDAMEDClass I (EU MDR)
Ref Bi15-014Model 8961103943644
Identity
- Trade Name
- Collin speculum 85x30mm EUDAMED
- Device Name
- Collin speculum 85x30mm EUDAMED
- Model / Reference
- 8961103943644 EUDAMEDBi15-014 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08961103943644 EUDAMED
- Basic UDI-DI
- 896110394Bi15-014KK EUDAMED
- EMDN Code
- L059001 VAGINAL SPECULUMS, REUSABLE EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Spain 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
Collin speculum 85x30mm by Battan International — 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 | 896110394Bi15-014KK | Class I | Active |
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Manufacturer
- Manufacturer
- Battan International
- EUDAMED SRN
- PK-MF-000043557
- Authorised Representative
- KHANG BAO INTERNATIONAL KFT HU-AR-000034102
Sources (1)
- EUDAMED 3248e5b7-a509-4837-bde9-a77325abc268 61 fields · synced Jul 13, 2026