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PRI Cellular Modem, EU

by Respironics Inc.

Ref 100226C

PRI Cellular Modem, EU (100226C) is a clinical laboratory information system (EU MDR Class I; FDA Class I; FDA product code OUG, Medical device data system) made by Respironics Inc., registered in EUDAMED on 23 Jan 2025 (Basic UDI-DI 0606959BM221LN) and listed in FDA GUDID since 30 Jun 2016 (UDI-DI 00606959026698), active as of 22 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 22 Oct 2026.

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number0606959BM221LN Basic UDI-DI 00606959026698UDI-DIDate23 Jan 2025RegisteredStatusActive
United StatesGUDID listing GUDID Number00606959026698 UDI-DI Date30 Jun 2016ListedStatusListed GUDID: in commercial distribution

Official records

Across registries

2 registries list this device

  • EUDAMED Basic UDI-DI 0606959BM221LN registered 23 Jan 2025 Active
  • FDA GUDID UDI-DI 00606959026698 listed 30 Jun 2016 Listed

Timeline

2 dated events

  1. Listed FDA GUDID 00606959026698
  2. Registered EUDAMED 0606959BM221LN

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  • Withdrawn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
PRI Cellular Modem, EU EUDAMED
PRI Cellular Modem GUDID
Generic name
Clinical laboratory information system
Model / Ref / Catalog
100226C, PRI Cellular Modem, EU
Primary DI / UDI-DI
00606959026698
Basic UDI-DI
0606959BM221LN
Direct marketing DI
00606959026698
FDA product code
OUG
EMDN code
Z1203019080 Various instruments for anaesthesia and pulmonary ventilation support - hardware accessories
GMDN term
Clinical laboratory information system
Device class
Class I
Regulation number
880.6310
EU registration type
Standard device
EU market of registration
Austria
GUDID distribution status
In Commercial Distribution

Truth per registry

2 sources · 1 field differs

FieldEUDAMEDGUDID
Model / referenceEUDAMED
100226C
GUDID
PRI Cellular Modem, EU

Manufacturer details

EUDAMED SRN
US-MF-000002301
Authorised representative
Philips Medical Systems Nederland B.V. NL-AR-000001422

Similar devices in this category

Other devices filed under VARIOUS INSTRUMENTS FOR ANAESTHESIA AND PULMONARY VENTILATION SUPPORT - HARDWARE ACCESSORIES.

Other devices from Respironics Inc.

See all devices from Respironics Inc. →

Properties

  • Prescription use
  • Premarket exempt
  • Serial number
Other properties (22, all answered No)