Identity
- Trade Name
- Friendship Medical EUDAMED
- Device Name
- Disposable EMG Monopolar Needle Electrodes EUDAMEDDisposable EMG Monopolar Needle Electrodes EUDAMED
- Model / Reference
- NEM2530 EUDAMED1097 EUDAMEDNEM EUDAMED
Identifiers
- Primary DI / UDI-DI
- 16955739010978 EUDAMED
- Basic UDI-DI
- B-16955739010978 EUDAMED695573906000LU EUDAMED
- EMDN Code
- Z121002 NERVOUS SYSTEM MONITORING SYSTEMS EUDAMEDZ12100480 ELECTROMYOGRAPHY INSTRUMENTS - HARDWARE ACCESSORIES EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Market of Registration
- Italy 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
Friendship Medical by Xi'an Friendship Medical Electronics Co., Ltd. — Class IIa — MDR, MDD — listed in EUDAMED — regulatory data on deviCERTS
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/MDR
European Union Active
CE/MDD
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | B-16955739010978 | Class IIa | Active |
| EUDAMED | European Union | CE/MDD | B-16955739010978 | Class IIa | Active |
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Manufacturer
- Manufacturer
- Xi'an Friendship Medical Electronics Co., Ltd.
- EUDAMED SRN
- CN-MF-000004202
- Authorised Representative
- Friendship Europe ApS DK-AR-000001593
Sources (2)
- EUDAMED 6d08d753-a7de-4645-9280-524449674c2e 61 fields · synced Oct 6, 2026
- EUDAMED da6f4859-8ca2-4834-a62c-6b901679b640 61 fields · synced May 17, 2026