Identity
- Trade Name
- Ochsner trocar 10cm 4 2/3mm EUDAMED
- Device Name
- Ochsner trocar 10cm 4 2/3mm EUDAMED
- Model / Reference
- Bi1-137 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08961103940681 EUDAMED
- Basic UDI-DI
- 896110394Bi1-137CB EUDAMED
- EMDN Code
- A060202 TROCAR DRAINAGES 3/4 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
Ochsner trocar 10cm 4 2/3mm 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 | 896110394Bi1-137CB | 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 16bb0930-e8c5-4de6-9dff-6e270da987ee 61 fields · synced Jul 27, 2026