Identity
- Trade Name
- Dental Splints EUDAMED
- Device Name
- Dental Splints EUDAMED
- Model / Reference
- SP01,SP02 EUDAMEDSP02 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06978049072507 EUDAMED
- Basic UDI-DI
- 697804907MP08Q9 EUDAMED
- EMDN Code
- Q010699 MATERIALS FOR THE PREPARATION OF CUSTOM-MADE DENTAL DEVICES - OTHER EUDAMED
Classification
- Device Class
- Class I 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
Dental Splints by Anson Investment Development Co., Ltd. — Class I — 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 | 697804907MP08Q9 | Class I | Active |
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Manufacturer
- Manufacturer
- Anson Investment Development Co., Ltd.
- EUDAMED SRN
- CN-MF-000049926
- Authorised Representative
- MedNet EC-REP GmbH DE-AR-000000002
Sources (1)
- EUDAMED 7f348dbb-10fa-46c9-ab2a-c07bbd817516 61 fields · synced Jun 18, 2026