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NanoPass CAT01356

by Stryker Corp.

Part of a family of 8 devices: see the family page

Ref CAT01356Model 08858251003407ST

NanoPass CAT01356 is a device classified as Class IIa in the EU and Class I in the US made by Stryker Corp., registered in EUDAMED on 3 Nov 2026 (Basic UDI-DI 08858251003407ST) and listed in FDA GUDID since 4 Sep 2015 (UDI-DI 07613252632955), active as of 7 Nov 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 7 Nov 2026.

Regulatory status

as of registry sync 7 Nov 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number08858251003407ST Basic UDI-DI 07613252632955UDI-DIDate3 Nov 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number07613252632955 UDI-DI Date4 Sep 2015ListedStatusListed GUDID: in commercial distribution

Official records

Across registries

2 registries list this device

  • EUDAMED Basic UDI-DI 08858251003407ST registered 3 Nov 2026 Active
  • FDA GUDID UDI-DI 07613252632955 listed 4 Sep 2015 Listed

Timeline

2 dated events

  1. Listed FDA GUDID 07613252632955
  2. Registered EUDAMED 08858251003407ST

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  • Withdrawn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
NanoPass
Generic name
Suturing unit, single-use
Device name
SMBU_TF10462_Suture Passer
Model / Ref / Catalog
CAT01356, 08858251003407ST
Primary DI / UDI-DI
07613252632955
Basic UDI-DI
08858251003407ST
FDA product code
HWQ
EMDN code
K030205 Arthroscopy suture devices not included in other classes, single-use
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
Ireland
GUDID distribution status
In Commercial Distribution
Size
Angle — 45.0 degree

Truth per registry

2 sources · 1 field differs

FieldEUDAMEDGUDID
Device classEUDAMED
Class IIa
GUDID
Class I

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 ARTHROSCOPY SURGICAL INSTRUMENTS, SINGLE-USE.

Other devices from Stryker Corp.

See all devices from Stryker Corp. →

Properties

  • Supplied sterile
  • Single use
  • Contains CMR substances (carcinogenic, mutagenic or toxic to reproduction)
  • Prescription use
  • Premarket exempt
  • Lot / batch number
  • Expiration date
Other properties (18, all answered No)