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OsteoMed 355-0402-SP

by Osteomed Corp.

Ref 355-0402-SP

OsteoMed 355-0402-SP is a device classified as Class IIb in the EU and Class II in the US made by Osteomed Corp., registered in EUDAMED on 6 Nov 2026 (Basic UDI-DI B-00845694096102) and listed in FDA GUDID since 9 Jun 2016 (UDI-DI 00845694096102), active as of 7 Nov 2026.

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

CE MDD

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 7 Nov 2026.

Regulatory status

as of registry sync 7 Nov 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDD EUDAMED NumberB-00845694096102 Basic UDI-DI 00845694096102UDI-DIDate6 Nov 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number00845694096102 UDI-DI Date9 Jun 2016ListedStatusListed GUDID: in commercial distribution

Official records

Across registries

2 registries list this device

  • EUDAMED Basic UDI-DI B-00845694096102 registered 6 Nov 2026 Active
  • FDA GUDID UDI-DI 00845694096102 listed 9 Jun 2016 Listed

Timeline

2 dated events

  1. Listed FDA GUDID 00845694096102
  2. Registered EUDAMED B-00845694096102

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  • Withdrawn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

Trade name
Acumed EUDAMED
OsteoMed GUDID
Generic name
Orthopaedic fixation plate, non-bioabsorbable
Device name
Trial
Model / Ref / Catalog
355-0402-SP
Primary DI / UDI-DI
00845694096102
Basic UDI-DI
B-00845694096102
FDA product code
HRS
EMDN code
L091001 Instruments for insertion and extraction of materials for osteosynthesis, reusable
GMDN term
Orthopaedic fixation plate, non-bioabsorbable
Device class
Class IIb EUDAMED
Class II GUDID
Regulation number
888.3030
EU registration type
Legacy device (under a directive)
EU market of registration
Spain
GUDID distribution status
In Commercial Distribution
Size
Length — 36 Millimeter

Truth per registry

2 sources · 3 fields differ

FieldEUDAMEDGUDID
Device classEUDAMED
Class IIb
GUDID
Class II
Supplied sterileEUDAMED
No
GUDID
Yes
Sterilise before useEUDAMED
Yes
GUDID
No

Registry differences

EUDAMED and FDA GUDID describe the same product (same UDI-DI) and state different values:

  • Supplied sterile UDI-DI 00845694096102: EUDAMED states No, FDA GUDID states Yes.
  • Sterilise before use UDI-DI 00845694096102: EUDAMED states Yes, FDA GUDID states No.

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.

Related devices

Category: Orthopaedic fixation plate, non-bioabsorbable

Similar devices in this category

Other devices filed under INSTRUMENTS FOR INSERTION AND EXTRACTION OF MATERIALS FOR OSTEOSYNTHESIS, REUSABLE.

Other devices from Osteomed Corp.

See all devices from Osteomed Corp. →

Properties

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