Identity
- Trade Name
- PK Thomas Set of 5 EUDAMED
- Device Name
- PK Thomas Set of 5 EUDAMED
- Model / Reference
- MD3101 EUDAMED
Identifiers
- Primary DI / UDI-DI
- G520MD31010 EUDAMED
- Basic UDI-DI
- ++G520MD3101K8 EUDAMED
- EMDN Code
- L159017 DENTAL RESTORATION CARVERS, REUSABLE EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Germany EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Implantable
No
EUDAMED
Reusable
Yes
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
PK Thomas Set of 5 by Medspo — 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 | ++G520MD3101K8 | Class I | Active |
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Manufacturer
- Manufacturer
- Medspo
- EUDAMED SRN
- PK-MF-000037594
- Authorised Representative
- ANTEX MEDI SOLUTION DE-AR-000008078
Sources (1)
- EUDAMED 2d39283f-0157-4725-98b5-d5792b90c608 61 fields · synced Jul 15, 2026