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Friendship Medical

EUDAMEDFDA UDI

Class I (EU MDR)

Ref 2018Model SEAg-C-1.5/100/22×30

by Xi'an Friendship Medical Electronics Co., Ltd.

Identity

Trade Name
Friendship Medical EUDAMEDFDA UDI
Generic Name
Electrode conductive medium FDA UDI
Device Name
Disposable Pre-Gelled Surface Electrodes (Central,Ag/AgCl) EUDAMED
Model / Reference
SEAg-C-1.5/100/22×30 EUDAMEDFDA UDI
2018 EUDAMED

Identifiers

Primary DI / UDI-DI
16955739020182 EUDAMEDFDA UDI
Basic UDI-DI
B-16955739020182 EUDAMED
510(k) Number
K110289 FDA UDI
FDA Product Code
GXY FDA UDI
EMDN Code
Z121002 NERVOUS SYSTEM MONITORING SYSTEMS EUDAMED
GMDN Term
Electrode conductive medium FDA UDI

Classification

Device Class
Class I EUDAMED
Class II FDA UDI
Regulation Number
882.1320 FDA UDI
Market of Registration
Italy EUDAMED
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

No

EUDAMEDFDA UDI

Single Use

Yes

FDA UDI

Implantable

No

EUDAMEDFDA UDI

Reusable

No

EUDAMED

Contains Latex

No

EUDAMEDFDA UDI

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

Prescription Use

Yes

FDA UDI

Over-the-Counter

No

FDA UDI

Convenience Kit

No

FDA UDI

Combination Product

No

FDA UDI

HCT/P

No

FDA UDI

Premarket Exempt

No

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

No

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

Yes

FDA UDI

Friendship Medical by Xi'an Friendship Medical Electronics Co., Ltd. — Class I — MDD, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS

Authorization Coverage (2 countries)

Regulatory Authorizations

European Union Active

CE/MDD

United States Pending data

FDA UDI

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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 c3728439-6ff7-41e6-9615-022f84b781e6 61 fields · synced Oct 6, 2026
  • FDA UDI d7b4fc60-4705-450a-b7c7-c87093114b16 33 fields · synced May 30, 2026