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Friendship Medical
EUDAMEDClass I (EU MDR)
Ref 5040Model DECL101500-TFModel DECL
Identity
- Trade Name
- Friendship Medical EUDAMED
- Device Name
- Medical EEG Ag/AgCl Cup Electrodes EUDAMED
- Model / Reference
- DECL101500-TF EUDAMED5040 EUDAMEDDECL EUDAMED
Identifiers
- Primary DI / UDI-DI
- 16955739050400 EUDAMED
- Basic UDI-DI
- B-16955739050400 EUDAMED695573904008LW EUDAMED
- Unit of Use DI
- 06955739050403 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
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 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-16955739050400 | Class I | Active |
| EUDAMED | European Union | CE/MDD | B-16955739050400 | 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 (2)
- EUDAMED c6ec59a8-7fc9-4bde-9de8-d6d82f35d54d 61 fields · synced Oct 6, 2026
- EUDAMED a21f341f-d9e9-4568-9229-17db279b76ef 61 fields · synced May 17, 2026