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Electrical handpieces used for cast cutting
EUDAMEDFDA UDIClass I (EU MDR)
Ref CSP-201
by Zethon Ltd
Identity
- Trade Name
- De Soutter Medical FDA UDI
- Generic Name
- Cast cutter, electrically-powered FDA UDI
- Device Name
- Electrical handpieces used for cast cutting EUDAMEDCSP-201 QUIETCAST PAEDIATRIC SAW FDA UDI
- Model / Reference
- CSP-201 EUDAMED1286994 FDA UDI
- Description
- CSP-201 QUIETCAST PAEDIATRIC SAW FDA UDI
Identifiers
- Catalog Number
- 1286994 FDA UDI
- Primary DI / UDI-DI
- 05060528013192 EUDAMEDFDA UDI
- Basic UDI-DI
- 50605201INT04MAN01WU EUDAMED
- Direct Marketing DI
- 05060528013192 EUDAMED
- FDA Product Code
- LGH FDA UDI
- EMDN Code
- Z12139005 PLASTER CAST SAWS EUDAMED
- GMDN Term
- Cast cutter, electrically-powered 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
Electrical handpieces used for cast cutting by Zethon Ltd — Class I — MDR, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
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 | 50605201INT04MAN01WU | 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 f19920a4-6202-421a-ba10-bf6d056be4ed 61 fields · synced Jun 18, 2026
- FDA UDI da541322-8097-46d6-863f-db8e259bf934 35 fields · synced May 30, 2026