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Prometheus Omni Splint Rolled PDF105

by Safeguard Medical Technologies Limited

Ref PML115

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

CE MDR

Valid until

Not listed

EUDAMED holds no validity date

FDA recalls

Not checked

No FDA submission to match recalls against

Documents

None, self-declared

Class I: no certifier involved

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source EUDAMED, GUDID, synced 23 Oct 2026. What this means

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number50604835710595 Basic UDI-DI 05060483570099UDI-DIDate28 May 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number05060483570099 UDI-DI Date4 May 2023ListedStatusListed GUDID: in commercial distribution

Certificates

0 certificates · EUDAMED

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

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  • Withdrawn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
Prometheus Omni Splint Rolled
Generic Name
First aid limb splint, mouldable, single-use
Model / Ref / Catalog
PML115 EUDAMED
PDF105 GUDID
PML105 GUDID
Primary DI / UDI-DI
05060483570099
Basic UDI-DI
50604835710595
FDA Product Code
NOC
EMDN Code
M03050299 Bandages and splints - other
GMDN Term
First aid limb splint, mouldable, single-use
Device Class
Class I
Regulation Number
878.3910
EU market of registration
Germany
GUDID distribution status
In Commercial Distribution

Truth per registry

2 sources · 1 field differs

FieldEUDAMEDGUDID
Model / ReferenceEUDAMED
PML115
GUDID
PDF105

Other devices from Safeguard Medical Technologies Limited

See all devices from Safeguard Medical Technologies Limited →

Properties

  • Single Use
  • Over-the-Counter
  • Premarket Exempt
  • Lot / Batch Number
  • Expiration Date

Other properties (19)

  • 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
  • Prescription Use: No
  • Convenience Kit: No
  • Combination Product: No
  • HCT/P: No
  • Serial Number: No
  • Manufacturing Date: No