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safePICO70 956-613

by Radiometer Medical ApS

Ref 956-613

safePICO70 956-613 is a device classified as Class IIa in the EU and Class II in the US made by Radiometer Medical ApS, registered in EUDAMED on 29 Sep 2026 (Basic UDI-DI 57006900011ME) and listed in FDA GUDID since 1 Sep 2016 (UDI-DI 05700699566133), active as of 23 Oct 2026.

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

CE MDR

Valid until

No date given

EUDAMED holds no validity date

FDA recalls

Not checked

No FDA submission to match recalls against

Documents

None linked in EUDAMED

A group certificate may exist

Trust

Unverified

Source EUDAMED, GUDID, synced 23 Oct 2026.

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number57006900011ME Basic UDI-DI 05700699566133UDI-DIDate29 Sep 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number05700699566133 UDI-DI Date1 Sep 2016ListedStatusListed GUDID: in commercial distribution

Official records

Across registries

2 registries list this device

  • EUDAMED Basic UDI-DI 57006900011ME registered 29 Sep 2026 Active
  • FDA GUDID UDI-DI 05700699566133 listed 1 Sep 2016 Listed

Timeline

2 dated events

  1. Listed FDA GUDID 05700699566133
  2. Registered EUDAMED 57006900011ME

Coverage

2 jurisdictions

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  • Withdrawn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

Specification

EUDAMED · GUDID

Trade name
safePICO 22Gx25mm Arterial blood sampler with 22Gx25mm needle, with vented TIPCAP, 1.5 mL, box of 100 pcs. EUDAMED
safePICO70 GUDID
Generic name
Arterial blood sampling kit
Model / Ref / Catalog
956-613
Primary DI / UDI-DI
05700699566133
Basic UDI-DI
57006900011ME
Unit of use DI
55700699566138
FDA product code
JKA, MEG
EMDN code
A02010502 Blood gas analysis, syringes with safety needle and kits
GMDN term
Arterial blood sampling kit
Device class
Class IIa EUDAMED
Class II GUDID
Regulation number
862.1675, 880.5860
EU registration type
Standard device
EU market of registration
Denmark
GUDID distribution status
In Commercial Distribution

Truth per registry

2 sources · 1 field differs

FieldEUDAMEDGUDID
Device classEUDAMED
Class IIa
GUDID
Class II

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

Related devices

Category: Arterial blood sampling kit

Similar devices in this category

Other devices filed under SINGLE-USE SYRINGES.

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Properties

  • Supplied sterile
  • Single use
  • Prescription use
  • Lot / batch number
  • Expiration date
Other properties (20, all answered No)