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MC 3FP-S Spritzekopf (gerade) / US-Version
EUDAMEDClass IIa (EU MDR)
Ref 798.300.21.US
Identity
- Trade Name
- MC 3FP-S Spritzekopf (gerade) / US-Version EUDAMED
- Device Name
- MC 3FP/3FP-S Spritze EUDAMED
- Model / Reference
- 798.300.21.US EUDAMED
Identifiers
- Primary DI / UDI-DI
- +D9511802301021 EUDAMED
- Basic UDI-DI
- ++D95118023JD EUDAMED
- Direct Marketing DI
- +D9511802301021 EUDAMED
- EMDN Code
- Q01010199 DENTAL RESTORATION DEVICES - OTHER EUDAMED
Classification
- Device Class
- Class IIa 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
Category: Dental appliance fabrication material, ceramic
MC 3FP-S Spritzekopf (gerade) / US-Version by Mytronic GmbH — Class IIa — MDR — listed in EUDAMED — regulatory data on deviCERTS
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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 | ++D95118023JD | Class IIa | Active |
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Manufacturer
- Manufacturer
- Mytronic GmbH
- EUDAMED SRN
- DE-MF-000013849
Sources (1)
- EUDAMED fbad56b9-4835-48fb-9bb1-f22c16d251e3 61 fields · synced Jun 18, 2026