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roeko GuttaFlow bioseal Mixing Tips, 24 pcs.
EUDAMEDClass I (EU MDR)
Ref 60019562Model GuttaFlow Sealer
Identity
- Trade Name
- roeko GuttaFlow bioseal Mixing Tips, 24 pcs. EUDAMED
- Device Name
- GuttaFlow bioseal Mix.Tips EUDAMED
- Model / Reference
- GuttaFlow Sealer EUDAMED60019562 EUDAMED
Identifiers
- Primary DI / UDI-DI
- E165600195622 EUDAMED
- Basic UDI-DI
- ++E165ENDO1GFBX002A8 EUDAMED
- EMDN Code
- Q01010299 ROOT CANAL FILLING DEVICES - OTHER EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Germany EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Implantable
No
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 Mixing Tips, 24 pcs. by Coltène/Whaledent GmbH + Co. KG — Class I — 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 | ++E165ENDO1GFBX002A8 | Class I | Active |
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Manufacturer
- Manufacturer
- Coltène/Whaledent GmbH + Co. KG
- EUDAMED SRN
- DE-MF-000005717
Sources (1)
- EUDAMED 5e9ec845-8fb1-4eb3-b255-0d0c769dec8d 61 fields · synced Jun 18, 2026