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Battery packs used in combination with cast saw to cut casts
EUDAMEDFDA UDIClass I (EU MDR)
Ref BP-201
by Zethon Ltd
Identity
- Trade Name
- De Soutter Medical FDA UDI
- Generic Name
- Portable/mobile rechargeable battery pack FDA UDI
- Device Name
- Battery packs used in combination with cast saw to cut casts EUDAMEDBP-201 BATTERY PACK - PRO FDA UDI
- Model / Reference
- BP-201 EUDAMED15250 FDA UDI
- Description
- BP-201 BATTERY PACK - PRO FDA UDI
Identifiers
- Catalog Number
- 15250 FDA UDI
- Primary DI / UDI-DI
- 05060528013208 EUDAMEDFDA UDI
- Basic UDI-DI
- 50605201INT03MAN12WL EUDAMED
- Direct Marketing DI
- 05060528013208 EUDAMED
- FDA Product Code
- LGH FDA UDI
- EMDN Code
- Z12139099 VARIOUS ORTHOPAEDIC AND TRAUMATOLOGY INSTRUMENTS - OTHER EUDAMED
- GMDN Term
- Portable/mobile rechargeable battery pack 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
Category: Orthopaedic guidewire, reusable
Battery packs used in combination with cast saw to cut casts by Zethon Ltd — Class I — MDR, FDA UDI — listed in EUDAMED, FDA GUDID
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Also classified as Orthopaedic guidewire, reusable.
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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 | 50605201INT03MAN12WL | 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 363151a9-4155-4031-918d-d0a6f639e415 61 fields · synced Jul 14, 2026
- FDA UDI 311ec06e-06db-45c7-860e-9365c6d9b657 35 fields · synced May 30, 2026