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Qalm Gel Pad Refill x3 FR/NL
EUDAMEDClass I (EU MDR)
Ref E-QALM-ML
by TensCare Ltd
Identity
- Trade Name
- Qalm Gel Pad Refill x3 FR/NL EUDAMED
- Device Name
- Gel pad, Refill 3 EUDAMED
- Model / Reference
- E-QALM-ML EUDAMED
Identifiers
- Primary DI / UDI-DI
- 05033435135561 EUDAMED
- Basic UDI-DI
- 5033435E00037X7 EUDAMED
- EMDN Code
- N010201 TENS SYSTEM ELECTRODES EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Netherlands 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 Gel Pad Refill x3 FR/NL by TensCare Ltd — 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 | 5033435E00037X7 | Class I | Active |
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Manufacturer
- Manufacturer
- TensCare Ltd
- EUDAMED SRN
- GB-MF-000004156
- Authorised Representative
- Advena Limited MT-AR-000000234
Sources (1)
- EUDAMED 66f1a1b5-9bbe-4ee7-93fa-ffe4fcb2e5be 61 fields · synced Jul 17, 2026