Identity
- Trade Name
- Amalgam Capsules EUDAMED
- Device Name
- Alloys for Dental Amalgam EUDAMED
- Model / Reference
- 600mg EUDAMED/ EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06935546102861 EUDAMED
- Basic UDI-DI
- B-06935546102861 EUDAMED
- EMDN Code
- Q01010101 AMALGAMS FOR RESTORATIVE DENTISTRY EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Market of Registration
- Poland EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Implantable
No
EUDAMED
Reusable
No
EUDAMED
Contains Latex
No
EUDAMED
Reprocessed
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
Amalgam Capsules by AT&M Biomaterials Co., Ltd. — Class IIa — MDD — listed in EUDAMED — regulatory data on deviCERTS
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/MDD
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDD | B-06935546102861 | Class IIa | Active |
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Manufacturer
- Manufacturer
- AT&M Biomaterials Co., Ltd.
- EUDAMED SRN
- CN-MF-000010556
- Authorised Representative
- Lotus NL B.V. NL-AR-000000121
Sources (1)
- EUDAMED bcb31405-2ae4-42d2-b8dd-486d4e0ae89b 61 fields · synced Jun 19, 2026