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ElectrodeCRF

by Cambridge Interventional LLC 116 variants

Ref CRF-U1550L

ElectrodeCRF (CRF-U1550L) is a device classified as Class IIb in the EU and Class II in the US made by Cambridge Interventional LLC, registered in EUDAMED on 19 Jul 2022 (Basic UDI-DI B-00811746032053), cleared under FDA 510(k) K192715 on 7 Jan 2020 and listed in FDA GUDID since 16 Oct 2020 (UDI-DI 00811746032053), active as of 22 Oct 2026.

Active European Union and United States. Also listed in GUDID (US).

CE MDD 510(k)

Valid until

No date given

CE: no date in EUDAMED. FDA: not time-limited

FDA recalls

None found

in data synced 22 Oct 2026

Documents

None linked in EUDAMED

A group certificate may exist

510(k) K192715

FDA submission, from GUDID

Trust

Unverified

Source EUDAMED, GUDID, synced 22 Oct 2026.

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDD EUDAMED NumberB-00811746032053 Basic UDI-DI 00811746032053UDI-DIDate19 Jul 2022RegisteredStatusActive
United StatesGUDID listing GUDID Number00811746032053 UDI-DI Date16 Oct 2020ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE GUDID from GUDID Substantially Equivalent · Traditional NumberK192715 Date7 Jan 2020DecidedStatusActive

Official records

Across registries

3 registries list this device

  • EUDAMED Basic UDI-DI B-00811746032053 registered 19 Jul 2022 Active
  • FDA 510(k) K192715 decided 7 Jan 2020 Active
  • FDA GUDID UDI-DI 00811746032053 listed 16 Oct 2020 Listed

Timeline

3 dated events

  1. Cleared FDA 510(k) K192715
  2. Listed FDA GUDID 00811746032053
  3. Registered EUDAMED B-00811746032053

Coverage

2 jurisdictions

United States of AmericaSwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered
  • European Union CE/MDD Active
  • United States FDA 510(k) Active

Specification

EUDAMED · GUDID

Generic name
Percutaneous radio-frequency ablation probe, tumour-ablation, monopolar
Device name
Crf-U1550L
Model / Ref / Catalog
CRF-U1550L
Primary DI / UDI-DI
00811746032053
Basic UDI-DI
B-00811746032053
510(k) Number
FDA product code
GEI
EMDN code
Z12010902 Electrosurgical units (esu) for general use
GMDN term
Percutaneous radio-frequency ablation probe, tumour-ablation, monopolar
Device class
Class IIb EUDAMED
Class II GUDID
Regulation number
878.4400
EU registration type
Legacy device (under a directive)
EU market of registration
Italy
GUDID distribution status
In Commercial Distribution

Truth per registry

2 sources · 1 field differs

FieldEUDAMEDGUDID
Device classEUDAMED
Class IIb
GUDID
Class II

Device class is stated on each registry's own scale: Class IIb in the EU (EUDAMED), Class II in the US (FDA GUDID). EU and US classes are different schemes, so this is not a disagreement.

Manufacturer details

EUDAMED SRN
US-MF-000021911
Authorised representative
MDSS GmbH DE-AR-000005430

Related devices

Category: Foot-switch, electrical

Similar devices in this category

Other devices filed under ELECTROSURGICAL UNITS (ESU) FOR GENERAL USE.

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Properties

  • Supplied sterile
  • Single use
  • Prescription use
  • Lot / batch number
  • Expiration date
Other properties (18, all answered No)