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Self-adhesive Electrodes
EUDAMEDClass I (EU MDR)
Ref Gourd Shaped Type BModel Round shape (Φ: 22, 32, 38, 40, 50, 60, 80mm), Square shape (40×40, 50×50mm), Rectangular shape (39×36, 48×40, 60×45, 80×40, 80×50, 90×50, 90×60, 110×70, 130×50, 130×80mm), Crescent Moon Shape, Gourd Shaped Type (A, B, C, D, E, F)
Identity
- Trade Name
- Self-adhesive Electrodes EUDAMED
- Device Name
- Self-adhesive Electrodes EUDAMED
- Model / Reference
- Round shape (Φ: 22, 32, 38, 40, 50, 60, 80mm), Square shape (40×40, 50×50mm), Rectangular shape (39×36, 48×40, 60×45, 80×40, 80×50, 90×50, 90×60, 110×70, 130×50, 130×80mm), Crescent Moon Shape, Gourd Shaped Type (A, B, C, D, E, F) EUDAMEDGourd Shaped Type B EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06901452000164 EUDAMED
- Basic UDI-DI
- 6901452SCE001MF EUDAMED
- EMDN Code
- Z12062885 NEUROMUSCULAR STIMULATION EQUIPMENT - CONSUMABLES EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Poland 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
Self-adhesive Electrodes by Suzhou Medical Appliance Factory — 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 | 6901452SCE001MF | Class I | Active |
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Manufacturer
- Manufacturer
- Suzhou Medical Appliance Factory
- EUDAMED SRN
- CN-MF-000015855
- Authorised Representative
- Metrax GmbH DE-AR-000005481
Sources (1)
- EUDAMED d58d7325-940c-4234-8754-21ed4e20ede1 61 fields · synced Jul 22, 2026