Identity
- Trade Name
- BTL-6000 TR-Therapy Elite EUDAMED
- Device Name
- BTL-6000 TR-Therapy EUDAMED
- Model / Reference
- P6000.501 EUDAMED
Identifiers
- Primary DI / UDI-DI
- B108049POELITEMEU00 EUDAMED
- Basic UDI-DI
- ++B108049POEUZ9 EUDAMED
- Direct Marketing DI
- B108049POELITEMEU00 EUDAMED
- EMDN Code
- Z12069099 VARIOUS PHYSIOTHERAPY AND REHABILITATION INSTRUMENTS - OTHER 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
BTL-6000 TR-Therapy Elite 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 | ++B108049POEUZ9 | 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 06a26fcc-fb4b-41fe-8b97-d85cde8e2b86 61 fields · synced Jul 21, 2026