← Back to catalogue

CadWell

EUDAMEDFDA UDI

Class I (EU MDR)

Ref 0005Model 302852-000-100

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

Identity

Trade Name
CadWell EUDAMEDFDA UDI
Generic Name
Electrode conductive medium FDA UDI
Device Name
Disposable Pre-Gelled Surface Electrodes (Ag/AgCl,Single) EUDAMED
Model / Reference
302852-000-100 EUDAMEDFDA UDI
0005 EUDAMED

Identifiers

Primary DI / UDI-DI
16955739000054 EUDAMEDFDA UDI
Basic UDI-DI
B-16955739000054 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

CadWell 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

Is this your device? Claim it to add documentation and request validation.

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 ff368fa7-3936-4972-8fb8-28e83c4bac52 61 fields · synced Oct 6, 2026
  • FDA UDI 5bbab608-72db-4bf6-9317-2fb018a0e0b4 33 fields · synced May 29, 2026