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roeko GuttaFlow bioseal Standard Set
EUDAMEDFDA 510(k)Class IIa (EU MDR)
Ref 60019560Model GuttaFlow Sealer
Identity
- Trade Name
- roeko GuttaFlow bioseal Standard Set EUDAMED
- Device Name
- GuttaFlow bioseal Standard Set EUDAMED
- Model / Reference
- GuttaFlow Sealer EUDAMED60019560 EUDAMED
Identifiers
- Primary DI / UDI-DI
- E165600195600 EUDAMED
- Basic UDI-DI
- ++E165ENDO1GFBXK0017T 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 Standard Set by Coltène/Whaledent GmbH + Co. KG — Class IIa — FDA_510K, MDR — listed in EUDAMED, FDA 510(k)
Authorization Coverage (2 countries)
Regulatory Authorizations
United States Active
FDA_510K
European Union Active
CE/MDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K032662 | Class IIa | Active |
| EUDAMED | European Union | CE/MDR | ++E165ENDO1GFBXK0017T | Class IIa | Active |
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Manufacturer
- Manufacturer
- Coltène/Whaledent GmbH + Co. KG
- EUDAMED SRN
- DE-MF-000005717
Sources (2)
- EUDAMED 0690ec23-ed65-425a-9276-93d9f5369eb1 61 fields · synced Oct 6, 2026
- FDA 510(k) K032662 1 fields · synced May 18, 2026