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Cadwell

EUDAMEDFDA UDI

Class IIa (EU MDR)

Ref 0019Model 302403-000

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

Identity

Trade Name
Cadwell EUDAMEDFDA UDI
Generic Name
Nerve-locating system probe, single-use FDA UDI
Device Name
Disposable Bipolar Nerve Stimulator Probe EUDAMED
Model / Reference
302403-000 EUDAMEDFDA UDI
0019 EUDAMED

Identifiers

Primary DI / UDI-DI
16955739000191 EUDAMEDFDA UDI
Basic UDI-DI
B-16955739000191 EUDAMED
510(k) Number
K112426 FDA UDI
FDA Product Code
ETN FDA UDI
EMDN Code
Z121002 NERVOUS SYSTEM MONITORING SYSTEMS EUDAMED
GMDN Term
Nerve-locating system probe, single-use FDA UDI

Classification

Device Class
Class IIa EUDAMED
Class II FDA UDI
Regulation Number
874.1820 FDA UDI
Market of Registration
Italy EUDAMED
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

Yes

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 IIa — 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 67a65701-8e51-41a2-ba0b-e6a12d752304 61 fields · synced May 30, 2026
  • FDA UDI d7e4debe-1eb3-4390-813e-fcd9d2857f58 33 fields · synced May 30, 2026