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Hygo Surge Tip

by J.H. Orsing AB

Ref HS25

Hygo Surge Tip (HS25) is a device classified as Class IIa in the EU and Class I in the US made by J.H. Orsing AB, registered in EUDAMED on 28 May 2026 (Basic UDI-DI 739350799902L3) and listed in FDA GUDID since 6 Dec 2022 (UDI-DI 07393507422011), 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 linked in EUDAMED

A group certificate may exist

Trust

Unverified

Source EUDAMED, GUDID, synced 23 Oct 2026.

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number739350799902L3 Basic UDI-DI 07393507422011UDI-DIDate28 May 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number07393507422011 UDI-DI Date6 Dec 2022ListedStatusListed GUDID: in commercial distribution

Official records

Across registries

2 registries list this device

  • EUDAMED Basic UDI-DI 739350799902L3 registered 28 May 2026 Active
  • FDA GUDID UDI-DI 07393507422011 listed 6 Dec 2022 Listed

Timeline

2 dated events

  1. Listed FDA GUDID 07393507422011
  2. Registered EUDAMED 739350799902L3

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  • Withdrawn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
Hygo Surge
Generic name
Dental suction system cannula, single-use
Device name
Surgical Aspirator Tips
Model / Ref / Catalog
HS25, Tip
Primary DI / UDI-DI
07393507422011
Basic UDI-DI
739350799902L3
Unit of use DI
07393507421014
FDA product code
EHZ
EMDN code
Q019001 Saliva aspirators and saliva absorbents
GMDN term
Dental suction system cannula, single-use
Device class
Class IIa EUDAMED
Class I GUDID
Regulation number
872.6640
EU registration type
Standard device
EU market of registration
Sweden
GUDID distribution status
In Commercial Distribution

Truth per registry

2 sources · 3 fields differ

FieldEUDAMEDGUDID
Model / referenceEUDAMED
HS25
GUDID
Tip
Device classEUDAMED
Class IIa
GUDID
Class I
Sterilise before useEUDAMED
Yes
GUDID
No

Registry differences

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

  • Sterilise before use UDI-DI 07393507422011: EUDAMED states Yes, FDA GUDID states No.

Device class is stated on each registry's own scale: Class IIa in the EU (EUDAMED), Class I in the US (FDA GUDID). EU and US classes are different schemes, so this is not a disagreement.

Related devices

Category: Dental suction system cannula, single-use

Similar devices in this category

Other devices filed under SALIVA ASPIRATORS AND SALIVA ABSORBENTS.

Other devices from J.H. Orsing AB

See all devices from J.H. Orsing AB →

Properties

  • Sterilise before use YesEUDAMEDNoGUDID
  • Single use
  • Prescription use
  • Premarket exempt
  • Lot / batch number
  • Manufacturing date
Other properties (19, all answered No)