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Omnicap 30.M0004.00

by Omnia Spa

Part of a family of 17 devices: see the family page

Ref 30.M0004.00

Omnicap 30.M0004.00 is a Class I device made by Omnia Spa, registered in EUDAMED on 29 Sep 2026 (Basic UDI-DI 805664650TF08CAPG4) and listed in FDA GUDID since 20 Jun 2023 (UDI-DI 08056646507757), 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, self-declared

Class I: no certifier involved

Trust

Unverified

Source EUDAMED, GUDID, synced 23 Oct 2026.

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number805664650TF08CAPG4 Basic UDI-DI 08056646507757UDI-DIDate29 Sep 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number08056646507757 UDI-DI Date20 Jun 2023ListedStatusListed GUDID: in commercial distribution

Official records

Across registries

2 registries list this device

  • EUDAMED Basic UDI-DI 805664650TF08CAPG4 registered 29 Sep 2026 Active
  • FDA GUDID UDI-DI 08056646507757 listed 20 Jun 2023 Listed

Certificates

0 certificates · EUDAMED

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

Timeline

2 dated events

  1. Listed FDA GUDID 08056646507757
  2. Registered EUDAMED 805664650TF08CAPG4

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  • Withdrawn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
Omnicap
Generic name
Surgical cap, single-use
Device name
Personal covers - Caps
Model / reference
30.M0004.00
Primary DI / UDI-DI
08056646507757
Basic UDI-DI
805664650TF08CAPG4
Unit of use DI
08056646507764
FDA product code
FYF
EMDN code
T0207 Caps and headwear (excluding personal protective equipment - PPE)
GMDN term
Surgical cap, single-use
Device class
Class I
Regulation number
878.4040
EU registration type
Standard device
EU market of registration
Italy
GUDID distribution status
In Commercial Distribution

Related devices

Category: Surgical cap, single-use

Similar devices in this category

Other devices filed under CAPS AND HEADWEAR (EXCLUDING PERSONAL PROTECTIVE EQUIPMENT - PPE).

Other devices from Omnia Spa

See all devices from Omnia Spa →

Properties

  • Single use
  • Premarket exempt
  • Lot / batch number
  • Manufacturing date
Other properties (21, all answered No)