Self-adhesive Electrode [EN]
by Bozhou Rongjian Medical Appliance Co., Ltd. China EUDAMED
Ref NK00091Model Round, Calabash, Elliptical, Rectangle, Butterfly, Rhombus, Saddle shape, Meniscus shape, Palm shape, Throat shape
EMDN N010201
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/MDR | Number697377419A00000013P | Date13 Aug 2026 | StatusActive |
Coverage
- Active
- Not covered
European Union — CE/MDR Active
Specification
- Device Name
- Self-adhesive Electrods
- Model / Reference
- Round, Calabash, Elliptical, Rectangle, Butterfly, Rhombus, Saddle shape, Meniscus shape, Palm shape, Throat shape, NK00091
- Primary DI / UDI-DI
- 06973774196160
- Basic UDI-DI
- 697377419A00000013P
- EMDN Code
- N010201 Tens system electrodes
- Device Class
- Class I
- Market of Registration
- Austria
Manufacturer details
- EUDAMED SRN
- CN-MF-000056295
- Authorised representative
- Caretechion GmbH DE-AR-000005946
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Properties & raw data
Show properties, registry sources and raw records
Other properties (12)
- Sterile: No
- Implantable: No
- Contains Latex: No
- Reprocessed: No
- CMR Substance: No
- Human-derived: No
- Human Tissues: No
- Animal Tissues: No
- Endocrine Disruptor: No
- Administering Medicine: No
- Measuring Function: No
- Incorporates Medicinal Product: No
Sources (1)
- EUDAMED df476c84-001b-4f5c-90e5-1228cada20e5