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Reflex Gold Feile
EUDAMEDClass IIa (EU MDR)
Ref ReGo.25.50Model ReGo.25.50 Reflex Gold Feile 25mm #50Ref ReGo.21.SETModel ReGo.21.SET Reflex Gold Feile 21mm #25-50Ref ReGo.25.SETModel ReGo.25.SET Reflex Gold Feile 25mm #25-50Ref ReGo.31.SETModel ReGo.31.SET Reflex Gold Feile 31mm #25-50Ref ReGo.25.40Model ReGo.25.40 Reflex Gold Feile 25mm #40Ref ReGo.31.40Model ReGo.31.40 Reflex Gold Feile 31mm #40Ref ReGo.21.25Model ReGo.21.25 Reflex Gold Feile 21mm #25
Identity
- Trade Name
- Reflex Gold Feile EUDAMED
- Device Name
- Reflex Gold Feile EUDAMED
- Model / Reference
- ReGo.25.50 Reflex Gold Feile 25mm #50 EUDAMEDReGo.25.50 EUDAMEDReGo.21.SET Reflex Gold Feile 21mm #25-50 EUDAMEDReGo.21.SET EUDAMEDReGo.25.SET Reflex Gold Feile 25mm #25-50 EUDAMEDReGo.25.SET EUDAMEDReGo.31.SET Reflex Gold Feile 31mm #25-50 EUDAMEDReGo.31.SET EUDAMEDReGo.25.40 Reflex Gold Feile 25mm #40 EUDAMEDReGo.25.40 EUDAMEDReGo.31.40 Reflex Gold Feile 31mm #40 EUDAMEDReGo.31.40 EUDAMEDReGo.21.25 Reflex Gold Feile 21mm #25 EUDAMEDReGo.21.25 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06942512512173 EUDAMED06942512512142 EUDAMED06942512512197 EUDAMED06942512512210 EUDAMED06942512512180 EUDAMED06942512512234 EUDAMED06942512512159 EUDAMED
- Basic UDI-DI
- B-06942512512173 EUDAMEDB-06942512512142 EUDAMEDB-06942512512197 EUDAMEDB-06942512512210 EUDAMEDB-06942512512180 EUDAMEDB-06942512512234 EUDAMEDB-06942512512159 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
Reflex Gold Feile 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-06942512512173 | 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 03891f84-ca9f-4477-b6a5-51a6bc02ff91 61 fields · synced Jul 25, 2026
- EUDAMED 4c206421-2449-4d9e-b0e7-c34c2f259d84 61 fields · synced May 16, 2026
- EUDAMED 52e84498-cd83-42db-810b-1d9931978e89 61 fields · synced May 17, 2026
- EUDAMED 4244a44b-5611-4c2c-9eed-34a90090d2a5 61 fields · synced May 18, 2026
- EUDAMED a80e2217-5ccd-434b-a563-ec076a2b6054 61 fields · synced May 18, 2026
- EUDAMED 3849d63b-ad79-43e3-b8b1-800091f1d624 61 fields · synced May 18, 2026
- EUDAMED 2634563d-0fbf-48e5-9ca3-3241e40e3564 61 fields · synced May 18, 2026