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Henry Schein Maxima
EUDAMEDFDA UDIClass I (EU MDR)
Ref 5720878Model TF-295 (HS)
Identity
- Trade Name
- Henry Schein Maxima EUDAMEDHenry Schein FDA UDI
- Generic Name
- Alginate dental impression material FDA UDI
- Device Name
- Alginates EUDAMEDMaxima Krom Alginate Plus 500g FDA UDI
- Model / Reference
- TF-295 (HS) EUDAMED5720878 EUDAMEDFDA UDI
- Description
- Maxima Krom Alginate Plus 500g FDA UDI
Identifiers
- Catalog Number
- 5720878 FDA UDI
- Primary DI / UDI-DI
- 10304040095598 EUDAMED00304040095591 FDA UDI
- Basic UDI-DI
- 03040429501DF EUDAMED
- Unit of Use DI
- 00304040095591 EUDAMED
- FDA Product Code
- ELW FDA UDI
- EMDN Code
- Q01020101 DENTAL IMPRESSION ALGINATES EUDAMED
- GMDN Term
- Alginate dental impression material FDA UDI
Classification
- Device Class
- Class I 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
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
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
No
FDA UDI
MR Safe FDA UDI
Henry Schein Maxima by Henry Schein, Inc. — 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 | 03040429501DF | Class I | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- Henry Schein Inc.
- EUDAMED SRN
- US-MF-000021683
- Authorised Representative
- Henry Schein Services GmbH DE-AR-000008001
Sources (2)
- EUDAMED 6584308e-eb26-429a-8f4e-4b6bddc26541 61 fields · synced Jul 19, 2026
- FDA UDI c7b96632-0452-42d4-b324-cb0a622a6eae 35 fields · synced May 30, 2026