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S.S Gutta Condensor Files
EUDAMEDClass IIa (EU MDR)
Ref CODE092180Model E09 S.S Gutta Condensor Files 4s 21 mm No 80Ref CODE092140Model E09 S.S Gutta Condensor Files 4s 21mm No.40Ref CODE092150Model E09 S.S Gutta Condensor Files 4s 21 mm No.50Ref CODE092245Model E09 S.S Gutta Condensor Files 4s 25mm No.45Ref CODE092135Model E09 S.S Gutta Condensor Files 4s 21mm No.35Ref CODE092160Model E09 S.S Gutta Condensor Files 4s 21 mm No.60Ref CODE092155Model E09 S.S Gutta Condensor Files 4s 21 mm No.55Ref CODE092130Model E09 S.S Gutta Condensor Files 4s 21mm No.30Ref CODE092230Model E09 S.S Gutta Condensor Files 4s 25mm No.30Ref CODE092145Model E09 S.S Gutta Condensor Files 4s 21mm No.45Ref CODE092255Model E09 S.S Gutta Condensor Files 4s 25mm No.55Ref CODE092225Model E09 S.S Gutta Condensor Files 4s 25mm No.25Ref CODE092235Model E09 S.S Gutta Condensor Files 4s 25mm No.35Ref CODE092170Model E09 S.S Gutta Condensor Files 4s 21 mm No.70Ref CODE092280Model E09 S.S Gutta Condensor Files 4s 25mm No.80
Identity
- Trade Name
- S.S Gutta Condensor Files EUDAMED
- Device Name
- Dental Root Canal Instruments Files EUDAMED
- Model / Reference
- E09 S.S Gutta Condensor Files 4s 21 mm No 80 EUDAMEDCODE092180 EUDAMEDE09 S.S Gutta Condensor Files 4s 21mm No.40 EUDAMEDCODE092140 EUDAMEDE09 S.S Gutta Condensor Files 4s 21 mm No.50 EUDAMEDCODE092150 EUDAMEDE09 S.S Gutta Condensor Files 4s 25mm No.45 EUDAMEDCODE092245 EUDAMEDE09 S.S Gutta Condensor Files 4s 21mm No.35 EUDAMEDCODE092135 EUDAMEDE09 S.S Gutta Condensor Files 4s 21 mm No.60 EUDAMEDCODE092160 EUDAMEDE09 S.S Gutta Condensor Files 4s 21 mm No.55 EUDAMEDCODE092155 EUDAMEDE09 S.S Gutta Condensor Files 4s 21mm No.30 EUDAMEDCODE092130 EUDAMEDE09 S.S Gutta Condensor Files 4s 25mm No.30 EUDAMEDCODE092230 EUDAMEDE09 S.S Gutta Condensor Files 4s 21mm No.45 EUDAMEDCODE092145 EUDAMEDE09 S.S Gutta Condensor Files 4s 25mm No.55 EUDAMEDCODE092255 EUDAMEDE09 S.S Gutta Condensor Files 4s 25mm No.25 EUDAMEDCODE092225 EUDAMEDE09 S.S Gutta Condensor Files 4s 25mm No.35 EUDAMEDCODE092235 EUDAMEDE09 S.S Gutta Condensor Files 4s 21 mm No.70 EUDAMEDCODE092170 EUDAMEDE09 S.S Gutta Condensor Files 4s 25mm No.80 EUDAMEDCODE092280 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06942512503812 EUDAMED06942512503751 EUDAMED06942512503775 EUDAMED06942512503874 EUDAMED06942512503744 EUDAMED06942512503799 EUDAMED06942512503782 EUDAMED06942512503737 EUDAMED06942512503843 EUDAMED06942512503768 EUDAMED06942512503898 EUDAMED06942512503836 EUDAMED06942512503850 EUDAMED06942512503805 EUDAMED06942512503928 EUDAMED
- Basic UDI-DI
- B-06942512503812 EUDAMEDB-06942512503751 EUDAMEDB-06942512503775 EUDAMEDB-06942512503874 EUDAMEDB-06942512503744 EUDAMEDB-06942512503799 EUDAMEDB-06942512503782 EUDAMEDB-06942512503737 EUDAMEDB-06942512503843 EUDAMEDB-06942512503768 EUDAMEDB-06942512503898 EUDAMEDB-06942512503836 EUDAMEDB-06942512503850 EUDAMEDB-06942512503805 EUDAMEDB-06942512503928 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 Gutta Condensor Files 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-06942512503812 | 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 (15)
- EUDAMED ab9777fc-9251-404b-8cf4-32b2f0fb1414 61 fields · synced Aug 3, 2026
- EUDAMED 9718e3a8-3d04-47ed-ad14-2f1ffeae86b3 61 fields · synced May 16, 2026
- EUDAMED 56bf85aa-1a14-4655-b2c9-3c50c1e38ac7 61 fields · synced May 16, 2026
- EUDAMED 1f013c31-9e9e-4a22-8c2e-a16a5db31c86 61 fields · synced May 17, 2026
- EUDAMED b0603b8b-fdf9-4dc8-9a92-429c34969e9d 61 fields · synced May 17, 2026
- EUDAMED dcbd5f3e-9a27-4c7c-8dee-069d44678e25 61 fields · synced May 17, 2026
- EUDAMED f78628b5-7345-4c17-a904-a0cbf6a29025 61 fields · synced May 17, 2026
- EUDAMED 29cd487a-2677-4b72-a945-a04f5fc93e70 61 fields · synced May 17, 2026
- EUDAMED 4fbcab0d-9e4e-4761-a68a-e91644cd6f13 61 fields · synced May 17, 2026
- EUDAMED d42e2368-6f6c-4a16-902b-b2591974aabb 61 fields · synced May 17, 2026
- EUDAMED f9a06f36-e1b0-4b90-a00b-6e3bf448e851 61 fields · synced May 18, 2026
- EUDAMED 01b04e48-e340-4de7-a7e9-24d6d78617cb 61 fields · synced May 19, 2026
- EUDAMED 5b327357-4a35-478f-bb9e-4bb8b2beb78b 61 fields · synced May 19, 2026
- EUDAMED 3b5f7d03-1847-4517-86d8-b294a4031d7d 61 fields · synced May 19, 2026
- EUDAMED ce7217b6-11f1-419c-80eb-e0522430ea1b 61 fields · synced May 19, 2026