Identity
- Trade Name
- Tuffier rib retractor 43x53mm EUDAMED
- Device Name
- Tuffier rib retractor 43x53mm EUDAMED
- Model / Reference
- Bi9-498 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08961103940179 EUDAMED
- Basic UDI-DI
- 896110394Bi9-498G6 EUDAMED
- EMDN Code
- L1206 LAPAROSCOPIC AND THORACOSCOPIC SURGERY SPREADERS AND RETRACTORS, 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
Tuffier rib retractor 43x53mm 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 | 896110394Bi9-498G6 | 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 d9731ccb-95ba-4ede-b3a8-e48c390677f3 61 fields · synced Jun 18, 2026