Identity
- Trade Name
- Stille osteotome 20mm EUDAMED
- Device Name
- Stille osteotome 20mm EUDAMED
- Model / Reference
- Bi8-181 EUDAMEDBi8-177 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08961103943347 EUDAMED08961103943309 EUDAMED
- Basic UDI-DI
- 896110394Bi8-181ET EUDAMED896110394Bi8-177F4 EUDAMED
- EMDN Code
- L090401 ORTHOPAEDIC SURGERY OSTEOTOMES, 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
Stille osteotome 20mm 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 | 896110394Bi8-181ET | 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 (2)
- EUDAMED 809ed021-2f2a-47d0-b36a-e63e000e7e35 61 fields · synced Jul 13, 2026
- EUDAMED eb4a5f8e-1cdc-4562-9a04-c25b3a5b7808 61 fields · synced May 17, 2026