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freeform fixgel 3 g
EUDAMEDClass IIa (EU MDR)
Ref 02829Model different Brand names
by DETAX GmbH
Identity
- Trade Name
- freeform fixgel 3 g EUDAMED
- Model / Reference
- different Brand names EUDAMED02829 EUDAMED
Identifiers
- Primary DI / UDI-DI
- +EDET028291 EUDAMED
- Basic UDI-DI
- ++EDET08364 EUDAMED
- EMDN Code
- Q010499 ORTHODONTIC DEVICES - OTHER EUDAMED
Classification
- Device Class
- Class IIa 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
freeform fixgel 3 g by DETAX 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 | ++EDET08364 | Class IIa | Active |
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Manufacturer
- Manufacturer
- DETAX GmbH
- EUDAMED SRN
- DE-MF-000022666
Sources (1)
- EUDAMED c8601d61-d8d3-4ae9-bd5f-dc1b3cff52d5 61 fields · synced Oct 6, 2026