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roeko GuttaFlow bioseal Refill Applicator
EUDAMEDClass IIa (EU MDR)
Ref 60019561Model GuttaFlow Sealer
Identity
- Trade Name
- roeko GuttaFlow bioseal Refill Applicator EUDAMED
- Device Name
- GuttaFlow bioseal Refill Applicator EUDAMED
- Model / Reference
- GuttaFlow Sealer EUDAMED60019561 EUDAMED
Identifiers
- Primary DI / UDI-DI
- E165600195610 EUDAMED
- Basic UDI-DI
- ++E165ENDO1GFBX001A6 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 GuttaFlow bioseal Refill Applicator 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 | ++E165ENDO1GFBX001A6 | Class IIa | Active |
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Manufacturer
- Manufacturer
- Coltène/Whaledent GmbH + Co. KG
- EUDAMED SRN
- DE-MF-000005717
Sources (1)
- EUDAMED 8fe6add3-67b0-4585-bb86-450dfeef9b7b 61 fields · synced Jul 26, 2026