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Hs Mios 5

by Haag-Streit AG

Ref 4000039

Hs Mios 5 (4000039) is an ophthalmic surgical microscope (EU MDR Class I; FDA Class I; FDA product code NFF, Device, Storage, Images, Ophthalmic) made by Haag-Streit AG, registered in EUDAMED on 21 Jun 2023 (Basic UDI-DI 764013298NEO900_CamMIOSQT) and listed in FDA GUDID since 13 Jun 2023 (UDI-DI 07640132987959), 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 Number764013298NEO900_CamMIOSQT Basic UDI-DI 07640132987959UDI-DIDate21 Jun 2023RegisteredStatusActive
United StatesGUDID listing GUDID Number07640132987959 UDI-DI Date13 Jun 2023ListedStatusListed GUDID: in commercial distribution

Official records

Across registries

2 registries list this device

  • EUDAMED Basic UDI-DI 764013298NEO900_CamMIOSQT registered 21 Jun 2023 Active
  • FDA GUDID UDI-DI 07640132987959 listed 13 Jun 2023 Listed

Timeline

2 dated events

  1. Listed FDA GUDID 07640132987959
  2. Registered EUDAMED 764013298NEO900_CamMIOSQT

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  • Withdrawn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
Hs Mios 5 EUDAMED
Neo 900 Hs Mios 5 GUDID
Generic name
Ophthalmic surgical microscope
Model / reference
4000039 EUDAMED
HS MIOS 5 GUDID
Primary DI / UDI-DI
07640132987959
Basic UDI-DI
764013298NEO900_CamMIOSQT
Direct marketing DI
07640132987959
FDA product code
NFF
EMDN code
Z1201118099 Instruments for operative microscopy - hardware accessories - other
GMDN term
Ophthalmic surgical microscope
Device class
Class I
Regulation number
892.2010
EU registration type
Standard device
EU market of registration
Bulgaria
GUDID distribution status
In Commercial Distribution

Truth per registry

2 sources · 1 field differs

FieldEUDAMEDGUDID
Model / referenceEUDAMED
4000039
GUDID
HS MIOS 5

Manufacturer details

EUDAMED SRN
CH-MF-000020981
Authorised representative
Haag-Streit Deutschland GmbH DE-AR-000025462

Similar devices in this category

Other devices filed under INSTRUMENTS FOR OPERATIVE MICROSCOPY - HARDWARE ACCESSORIES - OTHER.

Other devices from Haag-Streit AG

See all devices from Haag-Streit AG →

Properties

  • Premarket exempt
  • Serial number
  • Manufacturing date
Other properties (22, all answered No)