Cranial Access Drill
by Dansu-China Health Care Co., Ltd. EUDAMED
Active
Ref Rule 4 | main paragraph + 1st indentModel REF:D-5001-S
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/MDD | NumberB-06947329607821 | Date16 Jan 2025 | StatusActive |
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not known
- Not covered
European Union — CE/MDD Expiring
Certificates
No notified-body certificate is listed. Devices of this class are self-declared by the manufacturer.
Specification
- Model / Reference
- REF:D-5001-S, Rule 4 | main paragraph + 1st indent
- Primary DI / UDI-DI
- 06947329607821
- Basic UDI-DI
- B-06947329607821
- EMDN Code
- T0202 Surgical procedural kits (excluding surgical instrument kits)
- Device Class
- Class I
- Market of Registration
- Austria
Manufacturer details
- EUDAMED SRN
- CN-MF-000012826
- Authorised representative
- Shanghai International Holding Corp. GmbH(Europe) DE-AR-000000001
Other devices from Dansu-China Health Care Co., Ltd.
Properties
Other properties (10)
- Implantable: No
- Reusable: No
- Contains Latex: No
- Reprocessed: No
- Human-derived: No
- Human Tissues: No
- Animal Tissues: No
- Administering Medicine: No
- Measuring Function: No
- Incorporates Medicinal Product: No