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Drill Bit
EUDAMEDClass I (EU MDR)
Ref WDTO00443
by Shenzhen World Surgery Medical Device Technology Co., Ltd.
Identity
- Device Name
- Drill Bit EUDAMED
- Model / Reference
- WDTO00443 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06950292664807 EUDAMED
- Basic UDI-DI
- 695029260003012K2 EUDAMED
- Direct Marketing DI
- 06950292664807 EUDAMED
- EMDN Code
- L0916 ORTHOPAEDIC SURGERY BURS AND TIPS, REUSABLE EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Portugal 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
Category: Fluted surgical drill bit, reusable
Drill Bit by Shenzhen World Surgery Medical Device Technology Co., Ltd. — Class I — MDR — listed in EUDAMED — regulatory data on deviCERTS
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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 | 695029260003012K2 | Class I | Active |
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Manufacturer
- EUDAMED SRN
- CN-MF-000017319
- Authorised Representative
- Lotus NL B.V. NL-AR-000000121
Sources (1)
- EUDAMED b487f100-d917-4214-8bc4-c3f0f6385d98 61 fields · synced Jun 19, 2026