Identity
- Trade Name
- Friendship Medical EUDAMED
- Device Name
- Medical EEG Silver Cup Electrodes EUDAMED
- Model / Reference
- DES101000-TF EUDAMED5057 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 16955739050578 EUDAMED
- Basic UDI-DI
- B-16955739050578 EUDAMED
- EMDN Code
- Z121002 NERVOUS SYSTEM MONITORING SYSTEMS EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Italy EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Implantable
No
EUDAMED
Reusable
No
EUDAMED
Contains Latex
No
EUDAMED
Reprocessed
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
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 I — 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-16955739050578 | Class I | Active |
| EUDAMED | European Union | CE/MDD | B-16955739050578 | Class I | 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 (1)
- EUDAMED f7fb53fb-95b3-41ba-b2bc-7a9b428d8088 61 fields · synced May 23, 2026