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roeko GuttaFlow2 Standard Set
EUDAMEDClass IIa (EU MDR)
Ref 60026870Model GuttaFlow Sealer
Identity
- Trade Name
- roeko GuttaFlow2 Standard Set EUDAMED
- Device Name
- GuttaFlow2 Standard Set EUDAMED
- Model / Reference
- GuttaFlow Sealer EUDAMED60026870 EUDAMED
Identifiers
- Primary DI / UDI-DI
- E165600268700 EUDAMED
- Basic UDI-DI
- ++E165ENDO1GF2XK001ZM EUDAMED
- EMDN Code
- Q01010299 ROOT CANAL FILLING DEVICES - OTHER EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Market of Registration
- Germany EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Implantable
Yes
EUDAMED
Reusable
No
EUDAMED
Contains Latex
No
EUDAMED
Reprocessed
No
EUDAMED
CMR Substance
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Endocrine Disruptor
No
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
roeko GuttaFlow2 Standard Set by Coltène/Whaledent GmbH + Co. KG — Class IIa — MDR — listed in EUDAMED — regulatory data on deviCERTS
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/MDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | ++E165ENDO1GF2XK001ZM | Class IIa | Active |
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Manufacturer
- Manufacturer
- Coltène/Whaledent GmbH + Co. KG
- EUDAMED SRN
- DE-MF-000005717
Sources (1)
- EUDAMED 93d34c9b-beda-4af6-826d-a046f82ebc84 61 fields · synced Jun 18, 2026