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AFFINIS light body 2 x 50ml
EUDAMEDFDA UDIClass IIa (EU MDR)
Ref 6501Model Impression Material
by Dent4You AG
Identity
- Trade Name
- AFFINIS light body 2 x 50ml EUDAMEDAFFINIS FDA UDI
- Generic Name
- Silicone dental impression material FDA UDI
- Device Name
- AFFINIS light body 2 x 50ml FDA UDI
- Model / Reference
- Impression Material EUDAMED6501 EUDAMEDFDA UDI
- Description
- AFFINIS light body 2 x 50ml FDA UDI
Identifiers
- Primary DI / UDI-DI
- 07630243635115 EUDAMEDFDA UDI
- Basic UDI-DI
- 76303929ASIL190613K EUDAMED
- FDA Product Code
- ELW FDA UDI
- EMDN Code
- Q01020104 DENTAL IMPRESSION SILICONES EUDAMED
- GMDN Term
- Silicone dental impression material FDA UDI
Classification
- Device Class
- Class IIa EUDAMEDClass II FDA UDI
- Regulation Number
- 872.3660 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
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
Yes
FDA UDI
AFFINIS light body 2 x 50ml by Dent4You AG — Class IIa — 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 | 76303929ASIL190613K | Class IIa | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class IIa | Pending data |
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Manufacturer
- Manufacturer
- Dent4You AG
- EUDAMED SRN
- CH-MF-000028926
- Authorised Representative
- Dent4you GmbH DE-AR-000006093
Sources (2)
- EUDAMED 955218e6-31b7-4e2d-83a9-90f3e42f88f2 61 fields · synced Jun 18, 2026
- FDA UDI 1464d8f4-2b61-4ea3-9992-8bd44606ccbf 33 fields · synced May 30, 2026