Identity
- Trade Name
- Full set of transmitters EUDAMED
- Device Name
- Transmitters EUDAMED
- Model / Reference
- P014.060 EUDAMED
Identifiers
- Primary DI / UDI-DI
- B108214BUM9SETMEU00 EUDAMED
- Basic UDI-DI
- ++B108214BUMEUTD EUDAMED
- EMDN Code
- Z12139001 SHOCK WAVE THERAPY EQUIPMENT EUDAMED
Classification
- Device Class
- Class I 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
Full set of transmitters by BTL Industries Limited — Class I — 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 | ++B108214BUMEUTD | Class I | 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 04fbc169-2a0d-4609-bd7d-a82569aee3f7 61 fields · synced Jun 18, 2026