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Gates Drills (Gates Glidden)
EUDAMEDClass IIa (EU MDR)
Ref DT 180.28.4Model DT 180.28.4 Gates Drills (Gates Glidden) 28mm #4
Identity
- Trade Name
- Gates Drills (Gates Glidden) EUDAMED
- Device Name
- Gates Drills (Gates Glidden) EUDAMED
- Model / Reference
- DT 180.28.4 Gates Drills (Gates Glidden) 28mm #4 EUDAMEDDT 180.28.4 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06942512514832 EUDAMED
- Basic UDI-DI
- B-06942512514832 EUDAMED
- EMDN Code
- Q010507 ENDODONTIC INSTRUMENTS (CANAL ENLARGERS, FILES, RASPS, ETC.), SINGLE-USE EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Market of Registration
- Germany EUDAMED
Clinical & Handling
Sterile
Yes
EUDAMED
Implantable
No
EUDAMED
Reusable
No
EUDAMED
Contains Latex
No
EUDAMED
Reprocessed
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
Gates Drills (Gates Glidden) by Shenzhen Denco Medical Co., Ltd. — Class IIa — MDD — listed in EUDAMED — regulatory data on deviCERTS
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/MDD
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDD | B-06942512514832 | Class IIa | Active |
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Manufacturer
- Manufacturer
- Shenzhen Denco Medical Co., Ltd.
- EUDAMED SRN
- CN-MF-000014271
- Authorised Representative
- Share info GmbH DE-AR-000005132
Sources (1)
- EUDAMED 07550f18-7293-415a-9049-9ae4d9f54a40 61 fields · synced Jun 18, 2026