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Gates.glidden
EUDAMEDClass IIa (EU MDR)
Ref GATES.28.ASSModel GATES.28.ASS GATES.GLIDDEN 28mm #1(0.50),#2(0.70),#3(0.90),#4(1.10),#5(1.30),#6(1.50)Ref GATES.28.090Model GATES.28.090 GATES.GLIDDEN 28mm #3(0.90)Ref GATES.32.150Model GATES.32.150 GATES.GLIDDEN 32mm #6(1.50)Ref GATES.32.130Model GATES.32.130 GATES.GLIDDEN 32mm #5(1.30)Ref GATES.32.110Model GATES.32.110 GATES.GLIDDEN 32mm #4(1.10)Ref GATES.32.050Model GATES.32.050 GATES.GLIDDEN 32mm #1(0.50)Ref GATES.28.130Model GATES.28.130 GATES.GLIDDEN 28mm #5(1.30)
Identity
- Trade Name
- GATES.GLIDDEN EUDAMED
- Device Name
- GATES.GLIDDEN EUDAMED
- Model / Reference
- GATES.28.ASS GATES.GLIDDEN 28mm #1(0.50),#2(0.70),#3(0.90),#4(1.10),#5(1.30),#6(1.50) EUDAMEDGATES.28.ASS EUDAMEDGATES.28.090 GATES.GLIDDEN 28mm #3(0.90) EUDAMEDGATES.28.090 EUDAMEDGATES.32.150 GATES.GLIDDEN 32mm #6(1.50) EUDAMEDGATES.32.150 EUDAMEDGATES.32.130 GATES.GLIDDEN 32mm #5(1.30) EUDAMEDGATES.32.130 EUDAMEDGATES.32.110 GATES.GLIDDEN 32mm #4(1.10) EUDAMEDGATES.32.110 EUDAMEDGATES.32.050 GATES.GLIDDEN 32mm #1(0.50) EUDAMEDGATES.32.050 EUDAMEDGATES.28.130 GATES.GLIDDEN 28mm #5(1.30) EUDAMEDGATES.28.130 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06942512510865 EUDAMED06942512510827 EUDAMED06942512510926 EUDAMED06942512510919 EUDAMED06942512510902 EUDAMED06942512510872 EUDAMED06942512510841 EUDAMED
- Basic UDI-DI
- B-06942512510865 EUDAMEDB-06942512510827 EUDAMEDB-06942512510926 EUDAMEDB-06942512510919 EUDAMEDB-06942512510902 EUDAMEDB-06942512510872 EUDAMEDB-06942512510841 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.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-06942512510865 | 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 (7)
- EUDAMED 8a22affc-cbeb-4c78-ac59-7c2eba74d521 61 fields · synced Jul 24, 2026
- EUDAMED 84dbbba5-a323-4730-836f-e52acaa333cf 61 fields · synced May 16, 2026
- EUDAMED d18aa6f6-f5be-480b-863a-5d3eb577cdf8 61 fields · synced May 16, 2026
- EUDAMED 1b8cc3f1-f5fa-45c5-a6af-edff04467267 61 fields · synced May 17, 2026
- EUDAMED b7588ef1-b526-47f5-b459-357e6f856519 61 fields · synced May 18, 2026
- EUDAMED 0e9bde15-98aa-43a6-805a-70de9f80b007 61 fields · synced May 18, 2026
- EUDAMED 9569e1ce-1748-4abf-a482-e1dad791515a 61 fields · synced May 19, 2026