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primosplint
EUDAMEDClass IIa (EU MDR)
Ref PS100Model Dental Bite Splint Material
Identity
- Trade Name
- primosplint EUDAMED
- Model / Reference
- Dental Bite Splint Material EUDAMEDPS100 EUDAMED
Identifiers
- Primary DI / UDI-DI
- +EDELPS1001 EUDAMED
- Basic UDI-DI
- ++EDELTD10BUDI010011DU EUDAMED
- Unit of Use DI
- +EDELPS1000 EUDAMED
- EMDN Code
- Q010699 MATERIALS FOR THE PREPARATION OF CUSTOM-MADE DENTAL DEVICES - OTHER EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Market of Registration
- Germany 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
primosplint by DeltaMed GmbH — 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 | ++EDELTD10BUDI010011DU | Class IIa | Active |
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Manufacturer
- Manufacturer
- Deltamed GmbH
- EUDAMED SRN
- DE-MF-000007882
Sources (1)
- EUDAMED 571388ee-10a6-42ff-b034-474d55f330cc 61 fields · synced Jun 18, 2026