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S.S Gutta Condensor Files
EUDAMEDClass IIa (EU MDR)
Ref CODE0921ASSTModel E09 S.S Gutta Condensor Files 4s 21 mm Asst.
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 Asst. EUDAMEDCODE0921ASST EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06942512503829 EUDAMED
- Basic UDI-DI
- B-06942512503829 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-06942512503829 | 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 29129bdc-db9a-4880-9704-0368ddeb6d54 61 fields · synced Jun 19, 2026