Skip to content

Hoffee Suture Retriever 710000NS

by Aspen Surgical Products, Inc.

Ref 710000NS

Hoffee Suture Retriever 710000NS is a device classified as Class IIa in the EU and Class I in the US made by Aspen Surgical Products, Inc., registered in EUDAMED on 15 Jul 2026 (Basic UDI-DI 0840113213000NS3F) and listed in FDA GUDID since 22 Mar 2021 (UDI-DI 00840113230525), active as of 24 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 24 Oct 2026.

Regulatory status

as of registry sync 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number0840113213000NS3F Basic UDI-DI 00840113230525UDI-DIDate15 Jul 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number00840113230525 UDI-DI Date22 Mar 2021ListedStatusListed GUDID: in commercial distribution

Official records

Across registries

2 registries list this device

  • EUDAMED Basic UDI-DI 0840113213000NS3F registered 15 Jul 2026 Active
  • FDA GUDID UDI-DI 00840113230525 listed 22 Mar 2021 Listed

Timeline

2 dated events

  1. Listed FDA GUDID 00840113230525
  2. Registered EUDAMED 0840113213000NS3F

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  • Withdrawn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
Hoffee®, Green Genie, suture passer, aspen surgical® EUDAMED
Hoffee Suture Retriever GUDID
Generic name
Suturing unit, single-use
Device name
Suture Retriever (non-sterile)
Model / reference
710000NS
Primary DI / UDI-DI
00840113230525
Basic UDI-DI
0840113213000NS3F
FDA product code
LXH
EMDN code
H9099 Suture devices - other
GMDN term
Suturing unit, single-use
Device class
Class IIa EUDAMED
Class I GUDID
Regulation number
888.4540
EU registration type
Standard device
EU market of registration
Netherlands
GUDID distribution status
In Commercial Distribution

Truth per registry

2 sources · 3 fields differ

FieldEUDAMEDGUDID
Device classEUDAMED
Class IIa
GUDID
Class I
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 00840113230525: EUDAMED states No, FDA GUDID states Yes.
  • Sterilise before use UDI-DI 00840113230525: 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: Suturing unit, single-use

Similar devices in this category

Other devices filed under SUTURE DEVICES - OTHER.

Other devices from Aspen Surgical Products, Inc.

See all devices from Aspen Surgical Products, Inc. →

Properties

  • Supplied sterile NoEUDAMEDYesGUDID
  • Sterilise before use YesEUDAMEDNoGUDID
  • Single use
  • Premarket exempt
  • Lot / batch number
  • Serial number
  • Manufacturing date
Other properties (18, all answered No)