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Suture Passer Needle steril

by RZ-Medizintechnik GmbH

Ref 225-820-219S

Active European Union. Also listed in GUDID (US).

CE MDR

Valid until

Not listed

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

Registry data, not yet checked by deviCERTS. Source EUDAMED, GUDID, synced 24 Oct 2026. What this means

Regulatory status

as of registry sync 24 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing GUDID Number04049197518734 UDI-DI Date19 Jun 2024ListedStatusListed GUDID: in commercial distribution
European UnionCE/MDR EUDAMED Number40491975225-820-SPSQW Basic UDI-DI 04049197518734UDI-DIDate30 Jan 2023RegisteredStatusActive

Certificates

0 certificates · EUDAMED

EUDAMED lists no certificate for this device's Basic UDI-DI.

A certificate issued for a device group may exist without being linked here.

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  • Withdrawn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
Suture Passer Needle steril EUDAMED
RZ Medizintechnik GmbH GUDID
Generic Name
Arthroscopic suturing unit
Device Name
Suture Passer System
Model / Ref / Catalog
225-820-219S
Description
Needle with lateral opening 0,3x240mm f Suture Passer 225-820-217 sterile packed, package of 6pcs.
Primary DI / UDI-DI
04049197518734
Basic UDI-DI
40491975225-820-SPSQW, 40491975225-820-SPNQL
Direct Marketing DI
04049197518734
FDA Product Code
GAB
EMDN Code
H900899 Single-use instruments for sutures - other
GMDN Term
Arthroscopic suturing unit
Device Class
Class IIa EUDAMED
Class I GUDID
Regulation Number
878.4800
EU market of registration
Germany
GUDID distribution status
In Commercial Distribution

Truth per registry

2 sources · 1 field differs

FieldEUDAMEDGUDID
Device ClassEUDAMED
Class IIa
GUDID
Class I

Manufacturer details

EUDAMED SRN
DE-MF-000005616

Other devices from RZ-Medizintechnik GmbH

See all devices from RZ-Medizintechnik GmbH →

Properties

  • Sterile
  • Single Use
  • Reusable YesEUDAMEDNoEUDAMED
  • Prescription Use
  • Premarket Exempt
  • Lot / Batch Number
  • Expiration Date

Other properties (17)

  • Implantable: No
  • Contains Latex: No
  • Reprocessed: No
  • CMR Substance: No
  • Human-derived: No
  • Human Tissues: No
  • Animal Tissues: No
  • Endocrine Disruptor: No
  • Administering Medicine: No
  • Measuring Function: No
  • Incorporates Medicinal Product: No
  • Over-the-Counter: No
  • Convenience Kit: No
  • Combination Product: No
  • HCT/P: No
  • Serial Number: No
  • Manufacturing Date: No