Open Drill (Ⅲ)
by Beijing Fule Science & Technology Development Co., Ltd. 2 variants
Part of a family of 82 devices: see the family page
Ref 103-018
Open Drill (Ⅲ) (103-018) is a Class I device made by Beijing Fule Science & Technology Development Co., Ltd., registered in EUDAMED on 16 Mar 2026 (Basic UDI-DI 69367451SFSI01WJ), active as of 25 Oct 2026.
Active
CE MDR
Valid until
No date given
FDA recalls
Not applicable
Documents
None linked in EUDAMED
Trust
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/MDR | Number69367451SFSI01WJ 06936745120687 | Date16 Mar 2026 | StatusActive |
Official records
- EUDAMED public site 69367451SFSI01WJ
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
European Union — CE/MDR Active
Specification
- Device name
- Spinal Fixation Surgical Instrument
- Model / reference
- 103-018
- Primary DI / UDI-DI
- 06936745120687
- Basic UDI-DI
- 69367451SFSI01WJ
- Direct marketing DI
- 06936745120687
- EMDN code
- L0927 Orthopaedic surgery manual perforators, reusable
- Device class
- Class I
- EU registration type
- Standard device
- EU market of registration
- Czechia
Manufacturer details
- EUDAMED SRN
- CN-MF-000006511
- Authorised representative
- Shanghai International Holding Corp. GmbH(Europe) DE-AR-000000001
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