Identity
- Trade Name
- FSWT applicator BTL-294-1 EUDAMED
- Device Name
- FSWT applicator BTL-294-1 EUDAMED
- Model / Reference
- P094.002 EUDAMED
Identifiers
- Primary DI / UDI-DI
- B108294APMEU00 EUDAMED
- Basic UDI-DI
- ++B108294APEUXH EUDAMED
- Direct Marketing DI
- B108294APMEU00 EUDAMED
- EMDN Code
- Z12139001 SHOCK WAVE THERAPY EQUIPMENT EUDAMED
Classification
- Device Class
- Class IIb EUDAMED
- Market of Registration
- Northern Ireland 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
FSWT applicator BTL-294-1 by BTL Industries Limited — Class IIb — 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 | ++B108294APEUXH | Class IIb | Active |
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Manufacturer
- Manufacturer
- BTL Industries Limited
- EUDAMED SRN
- GB-MF-000034894
- Authorised Representative
- BTL ITALIA S.r.l. IT-AR-000020508
Sources (1)
- EUDAMED 8cdf57b8-053e-4c50-bb3b-1cc23ebc5ff0 61 fields · synced Jul 13, 2026