Identity
- Trade Name
- Open Drill (Ⅳ) EUDAMED
- Device Name
- Spinal Fixation Surgical Instrument EUDAMED
- Model / Reference
- 107-400 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06936745120700 EUDAMED
- Basic UDI-DI
- 69367451SFSI01WJ EUDAMED
- Direct Marketing DI
- 06936745120700 EUDAMED
- EMDN Code
- L0927 ORTHOPAEDIC SURGERY MANUAL PERFORATORS, REUSABLE EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Czechia 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
Open Drill (Ⅳ) by Beijing Fule Science & Technology Development Co., Ltd. — 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 | 69367451SFSI01WJ | Class I | Active |
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Manufacturer
- EUDAMED SRN
- CN-MF-000006511
- Authorised Representative
- Shanghai International Holding Corp. GmbH(Europe) DE-AR-000000001
Sources (1)
- EUDAMED 2dce5ac9-8e54-4a3e-ae28-d79b6a4f4c64 61 fields · synced Oct 6, 2026