Identity
- Trade Name
- Ceramill A-Splint 98x20/10 EUDAMED
- Device Name
- Polymers temporary / Kunststoffe temporär EUDAMED
- Model / Reference
- 761089 EUDAMED
Identifiers
- Primary DI / UDI-DI
- E4947610891 EUDAMED
- Basic UDI-DI
- ++E494ASPLINT6D EUDAMED
- EMDN Code
- Q010699 MATERIALS FOR THE PREPARATION OF CUSTOM-MADE DENTAL DEVICES - OTHER EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Market of Registration
- Austria 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
Ceramill A-Splint 98x20/10 by Amann Girrbach AG — 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 | ++E494ASPLINT6D | Class IIa | Active |
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Manufacturer
- Manufacturer
- Amann Girrbach AG
- EUDAMED SRN
- AT-MF-000000252
Sources (1)
- EUDAMED 3fd66b62-8462-4c39-a0ba-3b3ad80c0b01 61 fields · synced Jun 18, 2026