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CadWell

by Xi'an Friendship Medical Electronics Co., Ltd. 53 variants

Ref 1328Model 302360-000-048

Active European Union. Also listed in GUDID (US).

CE MDD

Valid until

Not listed

EUDAMED holds no validity date

FDA recalls

None found

in data synced 25 Oct 2026

Documents

None linked in EUDAMED

A group certificate may exist

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source EUDAMED, GUDID, synced 25 Oct 2026. What this means

Regulatory status

as of registry sync 25 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDD EUDAMED NumberB-16955739013283 Basic UDI-DI 16955739013283UDI-DIDate17 Sep 2022RegisteredStatusActive
United StatesGUDID listing GUDID Number16955739013283 UDI-DI Date31 Jan 2018ListedStatusListed GUDID: in commercial distribution

Certificates

0 certificates · EUDAMED

EUDAMED lists no certificate for this device's Basic UDI-DI.

A certificate issued for a device group may exist without being linked here.

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 25 Oct 2026.

Coverage

2 jurisdictions

United States of AmericaSwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered
  • European Union CE/MDD Active
  • United States GUDID listing Listed

Specification

EUDAMED · GUDID

Generic Name
Subdermal needle electrode
Device Name
Disposable Corkscrew Needle Electrodes(Twisted)
Model / Reference
302360-000-048, 1328
Primary DI / UDI-DI
16955739013283
Basic UDI-DI
B-16955739013283
510(k) Number
FDA Product Code
GXZ
EMDN Code
Z121002 Nervous system monitoring systems
GMDN Term
Subdermal needle electrode
Device Class
Class IIa EUDAMED
Class II GUDID
Regulation Number
882.1350
EU market of registration
Italy
GUDID distribution status
In Commercial Distribution
Sterilization Method
Ethylene Oxide

Truth per registry

2 sources · 1 field differs

FieldEUDAMEDGUDID
Device ClassEUDAMED
Class IIa
GUDID
Class II

Manufacturer details

EUDAMED SRN
CN-MF-000004202
Authorised representative
Friendship Europe ApS DK-AR-000001593

Other devices from Xi'an Friendship Medical Electronics Co., Ltd.

See all devices from Xi'an Friendship Medical Electronics Co., Ltd. →

Properties

  • Sterile
  • Single Use
  • Prescription Use
  • Lot / Batch Number
  • Expiration Date
  • Manufacturing Date

Other properties (16)

  • Implantable: No
  • Reusable: No
  • Contains Latex: No
  • Reprocessed: No
  • Human-derived: No
  • Human Tissues: No
  • Animal Tissues: No
  • Administering Medicine: No
  • Measuring Function: No
  • Incorporates Medicinal Product: No
  • Over-the-Counter: No
  • Convenience Kit: No
  • Combination Product: No
  • HCT/P: No
  • Premarket Exempt: No
  • Serial Number: No