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roeko GuttaFlow2 Mixing Tips, 24 pcs.
EUDAMEDFDA UDIClass I (EU MDR)
Ref 60013719Model GuttaFlow Sealer
Identity
- Trade Name
- roeko GuttaFlow2 Mixing Tips, 24 pcs. EUDAMEDROEKO GuttaFlow®2 FDA UDI
- Generic Name
- Dental material mixing nozzle FDA UDI
- Device Name
- GuttaFlow2 Mixing Tips EUDAMEDROEKO GuttaFlow®2 Mixing tips FDA UDI
- Model / Reference
- GuttaFlow Sealer EUDAMED60013719 EUDAMEDFDA UDI
- Description
- ROEKO GuttaFlow®2 Mixing tips FDA UDI
Identifiers
- Catalog Number
- 60013719 FDA UDI
- Primary DI / UDI-DI
- E165600137192 EUDAMEDFDA UDI
- Basic UDI-DI
- ++E165ENDO1GF2X00253 EUDAMED
- FDA Product Code
- DZN FDA UDI
- EMDN Code
- Q01010299 ROOT CANAL FILLING DEVICES - OTHER EUDAMED
- GMDN Term
- Dental material mixing nozzle FDA UDI
Classification
- Device Class
- Class I EUDAMEDFDA UDI
- Regulation Number
- 872.4565 FDA UDI
- Market of Registration
- Germany EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
EUDAMEDFDA UDI
Single Use
Yes
FDA UDI
Implantable
No
EUDAMEDFDA UDI
Reusable
No
EUDAMED
Contains Latex
No
EUDAMEDFDA UDI
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
Prescription Use
Yes
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
Yes
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
roeko GuttaFlow2 Mixing Tips, 24 pcs. by Coltène/Whaledent GmbH + Co. KG — Class I — MDR, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Active
CE/MDR
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | ++E165ENDO1GF2X00253 | Class I | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- Coltène/Whaledent GmbH + Co. KG
- EUDAMED SRN
- DE-MF-000005717
Sources (2)
- EUDAMED 350b2e6b-4326-4c99-845f-401fea64bca1 61 fields · synced Jul 10, 2026
- FDA UDI 74642a78-fba5-4182-be53-cb65d76467bb 35 fields · synced May 30, 2026