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Mains powered consoles, chargers and accessories used in combination with cast …
EUDAMEDFDA UDIClass I (EU MDR)
Ref PS-201
by Zethon Ltd
Identity
- Trade Name
- De Soutter Medical FDA UDI
- Generic Name
- Basic power supply, reusable FDA UDI
- Device Name
- Mains powered consoles, chargers and accessories used in combination with cast saw to cut casts EUDAMEDPS-201 POWER SUPPLY FDA UDI
- Model / Reference
- PS-201 EUDAMED15280 FDA UDI
- Description
- PS-201 POWER SUPPLY FDA UDI
Identifiers
- Catalog Number
- 15280 FDA UDI
- Primary DI / UDI-DI
- 05060528013222 EUDAMEDFDA UDI
- Basic UDI-DI
- 50605201INT03MAN06WR EUDAMED
- Direct Marketing DI
- 05060528013222 EUDAMED
- FDA Product Code
- LGH FDA UDI
- EMDN Code
- Z12139080 VARIOUS ORTHOPAEDIC AND TRAUMATOLOGY INSTRUMENTS - HARDWARE ACCESSORIES EUDAMED
- GMDN Term
- Basic power supply, reusable FDA UDI
Classification
- Device Class
- Class I EUDAMEDFDA UDI
- Regulation Number
- 888.5960 FDA UDI
- Market of Registration
- Netherlands EUDAMED
- Commercial Distribution
- Not in Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
EUDAMEDFDA UDI
Single Use
No
FDA UDI
Implantable
No
EUDAMEDFDA UDI
Reusable
No
EUDAMED
Contains Latex
No
EUDAMEDFDA UDI
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
Prescription Use
Yes
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
Yes
FDA UDI
Lot / Batch Number
No
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
MR Unsafe FDA UDI
Mains powered consoles, chargers and accessories used in combination with cast … by Zethon Ltd — Class I — MDR, FDA UDI — listed in EUDAMED, FDA GUDID
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Active
CE/MDR
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 50605201INT03MAN06WR | Class I | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- Zethon Ltd
- EUDAMED SRN
- GB-MF-000014309
- Authorised Representative
- De Soutter Medical Limited NL-AR-000000438
Sources (2)
- EUDAMED bee12ace-73e8-4f98-9ac4-bf45d17d2b9f 61 fields · synced Jul 9, 2026
- FDA UDI 8c8d27f0-2d08-4978-9b0a-7ec32209e7d6 35 fields · synced May 30, 2026