Identity
- Trade Name
- Stille osteotome EUDAMEDStille osteotome 25mm EUDAMED
- Device Name
- Stille osteotome EUDAMEDStille osteotome 25mm EUDAMED
- Model / Reference
- Bi8-167 EUDAMEDBi8-178 EUDAMEDBi8-182 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08961103943446 EUDAMED08961103943316 EUDAMED08961103943354 EUDAMED
- Basic UDI-DI
- 896110394Bi8-167EZ EUDAMED896110394Bi8-178F6 EUDAMED896110394Bi8-182EV 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 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 | 896110394Bi8-167EZ | 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 (3)
- EUDAMED 2341f9aa-3a58-4fa5-908d-2a9c9c59f241 61 fields · synced Jul 18, 2026
- EUDAMED 317e64b0-414b-4459-8dde-605310bc3ca8 61 fields · synced May 18, 2026
- EUDAMED ad58aa7f-048a-4160-a2b2-30eb272927db 61 fields · synced May 19, 2026