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Hu-Friedy

by Hu-Friedy Manufacturing Co., LLC 1,000+ variants

Ref IMS-1236Model Sterilization Packaging

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

CE MDR

Valid until

Not listed

EUDAMED holds no validity date

FDA recalls

None found

in data synced 25 Oct 2026

Documents

None, self-declared

Class I: no certifier involved

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/MDR EUDAMED Number0889950IMSSterilizationUG Basic UDI-DI 10889950002183UDI-DIDate8 Aug 2025RegisteredStatusActive
United StatesGUDID listing GUDID Number10889950002183 UDI-DI Date21 Sep 2016ListedStatusListed GUDID: in commercial distribution

Certificates

0 certificates · EUDAMED

No certifier certificate is listed. Devices of this class are self-declared by the manufacturer.

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  • Withdrawn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/MDR Active
  • United States GUDID listing Listed

Specification

EUDAMED · GUDID

Generic Name
Instrument management bag
Model / Ref / Catalog
Sterilization Packaging, IMS-1236
Primary DI / UDI-DI
10889950002183
Basic UDI-DI
0889950IMSSterilizationUG
Unit of Use DI
10889950035297
510(k) Number
FDA Product Code
KCT
EMDN Code
S01010101 Sterilisation pouches, flat, paper/plastic film
GMDN Term
Instrument management bag
Device Class
Class I EUDAMED
Class II GUDID
Regulation Number
880.6850
EU market of registration
Germany
GUDID distribution status
In Commercial Distribution

Truth per registry

2 sources · 1 field differs

FieldEUDAMEDGUDID
Device ClassEUDAMED
Class I
GUDID
Class II

Manufacturer details

EUDAMED SRN
US-MF-000017104
Authorised representative
Hu-Friedy Europe LLC & Co. KG DE-AR-000005530

Other devices from Hu-Friedy Manufacturing Co., LLC

See all devices from Hu-Friedy Manufacturing Co., LLC →

Properties

  • Single Use
  • Prescription Use
  • Lot / Batch Number

Other properties (21)

  • Sterile: No
  • Implantable: No
  • Reusable: No
  • Contains Latex: No
  • Reprocessed: No
  • CMR Substance: No
  • Human-derived: No
  • Human Tissues: No
  • Animal Tissues: No
  • Endocrine Disruptor: 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
  • Expiration Date: No
  • Manufacturing Date: No