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S.S Gates Drills
EUDAMEDClass IIa (EU MDR)
Ref CODE12325Model E12 S.S Gates Drills 6s 32mm No.5Ref CODE12283Model E12 S.S Gates Drills 6s 28mm No.3Ref CODE1232ASSTModel E12 S.S Gates Drills 6s 32mm Asst.Ref CODE12324Model E12 S.S Gates Drills 6s 32mm No.4Ref CODE12323Model E12 S.S Gates Drills 6s 32mm No.3Ref CODE12282Model E12 S.S Gates Drills 6s 28mm No.2Ref CODE1228ASSTModel E12 S.S Gates Drills 6s 28mm Asst.Ref CODE12281Model E12 S.S Gates Drills 6s 28mm No.1Ref CODE12284Model E12 S.S Gates Drills 6s 28mm No.4
Identity
- Trade Name
- S.S Gates Drills EUDAMED
- Device Name
- Dental Root Canal Instruments Files EUDAMED
- Model / Reference
- E12 S.S Gates Drills 6s 32mm No.5 EUDAMEDCODE12325 EUDAMEDE12 S.S Gates Drills 6s 28mm No.3 EUDAMEDCODE12283 EUDAMEDE12 S.S Gates Drills 6s 32mm Asst. EUDAMEDCODE1232ASST EUDAMEDE12 S.S Gates Drills 6s 32mm No.4 EUDAMEDCODE12324 EUDAMEDE12 S.S Gates Drills 6s 32mm No.3 EUDAMEDCODE12323 EUDAMEDE12 S.S Gates Drills 6s 28mm No.2 EUDAMEDCODE12282 EUDAMEDE12 S.S Gates Drills 6s 28mm Asst. EUDAMEDCODE1228ASST EUDAMEDE12 S.S Gates Drills 6s 28mm No.1 EUDAMEDCODE12281 EUDAMEDE12 S.S Gates Drills 6s 28mm No.4 EUDAMEDCODE12284 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06942512504192 EUDAMED06942512504109 EUDAMED06942512504215 EUDAMED06942512504185 EUDAMED06942512504178 EUDAMED06942512504093 EUDAMED06942512504147 EUDAMED06942512504086 EUDAMED06942512504116 EUDAMED
- Basic UDI-DI
- B-06942512504192 EUDAMEDB-06942512504109 EUDAMEDB-06942512504215 EUDAMEDB-06942512504185 EUDAMEDB-06942512504178 EUDAMEDB-06942512504093 EUDAMEDB-06942512504147 EUDAMEDB-06942512504086 EUDAMEDB-06942512504116 EUDAMED
- EMDN Code
- Q010507 ENDODONTIC INSTRUMENTS (CANAL ENLARGERS, FILES, RASPS, ETC.), SINGLE-USE EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Market of Registration
- Poland EUDAMED
Clinical & Handling
Sterile
No
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
S.S Gates Drills 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-06942512504192 | 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 (9)
- EUDAMED 492e065d-d7ba-44fb-bfe0-087cf90de21b 61 fields · synced Aug 4, 2026
- EUDAMED f0c1f899-aa44-4cfe-828b-21cedd1592f4 61 fields · synced May 16, 2026
- EUDAMED fd34247d-2ca2-41a5-906c-749a25b5f4fe 61 fields · synced May 17, 2026
- EUDAMED f6f5dbae-58df-4f25-aee1-3510a1a6aaa3 61 fields · synced May 17, 2026
- EUDAMED 805fbddf-cf53-468a-9128-0c59db1ea705 61 fields · synced May 17, 2026
- EUDAMED fd731180-00e6-4e5f-9a0c-0281f1a617f4 61 fields · synced May 18, 2026
- EUDAMED f98265bf-f7a7-4fb4-899f-7604b555e11b 61 fields · synced May 18, 2026
- EUDAMED 4e5fbbba-5ca7-46e8-80bc-aa8173bc5947 61 fields · synced May 18, 2026
- EUDAMED e0a2c4ed-9dab-48a0-af87-9a85c7077c34 61 fields · synced May 19, 2026