← Back to catalogue
Flow.rezi
EUDAMEDClass IIa (EU MDR)
Ref Flow.21.35Model Flow.21.35 FLOW.REZI 21mm 35/6%
Identity
- Trade Name
- FLOW.REZI EUDAMED
- Device Name
- FLOW.REZI EUDAMED
- Model / Reference
- Flow.21.35 FLOW.REZI 21mm 35/6% EUDAMEDFlow.21.35 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06975718058183 EUDAMED
- Basic UDI-DI
- B-06975718058183 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
Flow.rezi 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-06975718058183 | Class IIa | Active |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Shenzhen Denco Medical Co., Ltd.
- EUDAMED SRN
- CN-MF-000014271
- Authorised Representative
- Share info GmbH DE-AR-000005132
Sources (1)
- EUDAMED 609ee668-cb2d-4d14-9bdc-3d5e4e022baa 61 fields · synced Jun 18, 2026