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luxaprint shellac color black 100 ml
EUDAMEDFDA UDIClass IIa (EU MDR)
Ref 03856
Identity
- Trade Name
- luxaprint shellac color black 100 ml EUDAMEDFDA UDI
- Generic Name
- Earmould, custom-made FDA UDI
- Device Name
- Composite-Lack zum Versiegeln und Glätten für 3D EUDAMED
- Model / Reference
- 03856 EUDAMEDFDA UDI
Identifiers
- Primary DI / UDI-DI
- +EDET038561 EUDAMEDEDET038561 FDA UDI
- Basic UDI-DI
- ++EDET0265Q EUDAMED
- FDA Product Code
- ESD FDA UDI
- EMDN Code
- Q030499 OTOLOGY DEVICES - OTHER EUDAMED
- GMDN Term
- Earmould, custom-made FDA UDI
Classification
- Device Class
- Class IIa EUDAMEDClass I FDA UDI
- Regulation Number
- 874.3300 FDA UDI
- Market of Registration
- Germany EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
EUDAMEDFDA UDI
Single Use
No
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
No
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
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
luxaprint shellac color black 100 ml by DETAX GmbH & Co. KG — Class IIa — MDR, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union No Longer Active
CE/MDR
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | ++EDET0265Q | Class IIa | No Longer Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class IIa | Pending data |
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Manufacturer
- Manufacturer
- DETAX GmbH & Co. KG
- EUDAMED SRN
- DE-MF-000005995
Sources (2)
- EUDAMED 816e80d4-7188-448f-ba44-4039803acf9b 61 fields · synced Oct 6, 2026
- FDA UDI 24501ac7-6b48-41bf-8550-705157a18562 32 fields · synced May 29, 2026