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Subdermal Needle Electrodes
EUDAMEDClass IIa (EU MDR)
Ref 287-S121CModel 287-S121C, 287-S122C, 287-S125C, 287-S121C1, 287-S181C1, 287-S120C1, 287-P122C, 287-P124C, 287-P182C, 287-P184C
Identity
- Device Name
- Subdermal Needle Electrodes EUDAMED
- Model / Reference
- 287-S121C, 287-S122C, 287-S125C, 287-S121C1, 287-S181C1, 287-S120C1, 287-P122C, 287-P124C, 287-P182C, 287-P184C EUDAMED287-S121C EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06973770673511 EUDAMED
- Basic UDI-DI
- 697377067287PG EUDAMED
- EMDN Code
- N01010299 EEG ELECTRODES - OTHER EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Market of Registration
- France EUDAMED
Clinical & Handling
Sterile
Yes
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
Subdermal Needle Electrodes by Comepa medical device Co., 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 | 697377067287PG | Class IIa | Active |
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Manufacturer
- Manufacturer
- Comepa medical device Co., Ltd
- EUDAMED SRN
- CN-MF-000025234
- Authorised Representative
- COMEPA INDUSTRIES FR-AR-000007911
Sources (1)
- EUDAMED 5b8455b9-6096-48c3-abcd-a1a5d1a76385 61 fields · synced Jul 19, 2026