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Set of capacitive electrodes BTL-249-SC4
EUDAMEDClass IIb (EU MDR)
Ref P6000.511
Identity
- Trade Name
- Set of capacitive electrodes BTL-249-SC4 EUDAMED
- Device Name
- BTL-6000 TR-Therapy Accessory EUDAMED
- Model / Reference
- P6000.511 EUDAMED
Identifiers
- Primary DI / UDI-DI
- B108249ELCAPSETMEU00 EUDAMED
- Basic UDI-DI
- ++B108249APEUX7 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
Set of capacitive electrodes BTL-249-SC4 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 | ++B108249APEUX7 | 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 c9c8e690-cf87-46f1-ad85-5480376610ba 61 fields · synced Jul 9, 2026