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Mains powered consoles, chargers and accessories used in combination with surgi…
EUDAMEDClass I (EU MDR)
Ref PC-120
by Zethon Ltd
Identity
- Device Name
- Mains powered consoles, chargers and accessories used in combination with surgical power tools to ream, bur, drill and cut bone EUDAMED
- Model / Reference
- PC-120 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 05060528013345 EUDAMED
- Basic UDI-DI
- 50605201INT02MAN06WC EUDAMED
- Direct Marketing DI
- 05060528013345 EUDAMED
- EMDN Code
- Z12100980 INSTRUMENTS FOR MOTORISED NEUROSURGERY SYSTEMS - HARDWARE ACCESSORIES EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Netherlands 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
Mains powered consoles, chargers and accessories used in combination with surgi… by Zethon Ltd — Class I — MDR — listed in EUDAMED
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 | 50605201INT02MAN06WC | Class I | Active |
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Manufacturer
- Manufacturer
- Zethon Ltd
- EUDAMED SRN
- GB-MF-000014309
- Authorised Representative
- De Soutter Medical Limited NL-AR-000000438
Sources (1)
- EUDAMED cce50634-6951-4e8f-a9fe-270f1b1a8022 61 fields · synced Jun 20, 2026