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Qalm- Fr/It/De/Nl
EUDAMEDClass IIa (EU MDR)
Ref K-QALM- FR/IT/DE/NL
by TensCare Ltd
Identity
- Trade Name
- QALM- FR/IT/DE/NL EUDAMED
- Device Name
- Mynd EUDAMED
- Model / Reference
- K-QALM- FR/IT/DE/NL EUDAMED
Identifiers
- Primary DI / UDI-DI
- 05033435139491 EUDAMED
- Basic UDI-DI
- 5033435K00122DS5 EUDAMED
- EMDN Code
- Z120622 MUSCLE STIMULATORS EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Market of Registration
- France 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
Qalm- Fr/It/De/Nl by TensCare Ltd — Class IIa — 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 | 5033435K00122DS5 | Class IIa | Active |
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Manufacturer
- Manufacturer
- TensCare Ltd
- EUDAMED SRN
- GB-MF-000004156
- Authorised Representative
- Advena Limited MT-AR-000000234
Sources (1)
- EUDAMED d1c3d39a-dcf7-487a-9be7-ebd2791ea9ab 61 fields · synced Jul 13, 2026