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Mani Sutures Nylon - 7-0 Nylon

by Mani, Inc. 16 variants

Ref 3361S

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

CE MDR CE MDD

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
European UnionCE/MDR EUDAMED NumberB-04546951400781 Basic UDI-DI Date13 Nov 2025RegisteredStatusActive
European UnionCE/MDD EUDAMED NumberB-04546951400781 Basic UDI-DI Date13 Nov 2025RegisteredStatusActive
United StatesGUDID listing GUDID Number04546951400781 UDI-DI Date4 Jun 2016ListedStatusListed GUDID: in commercial distribution

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  • Withdrawn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, CE/MDD Active
  • United States GUDID listing Listed

Specification

EUDAMED · GUDID

Trade Name
Mani Sutures Nylon - 7-0 Nylon EUDAMED
MANI Sutures Nylon GUDID
Generic Name
Nylon suture, non-bioabsorbable, monofilament
Model / Ref / Catalog
3361S
Primary DI / UDI-DI
04546951400781, 04546951634773
Basic UDI-DI
B-04546951400781, 4546951000006ZK
FDA Product Code
GAR
EMDN Code
H010201010101 Polyamide monofilament with needle
GMDN Term
Nylon suture, non-bioabsorbable, monofilament
Device Class
Class IIb EUDAMED
Class II GUDID
Regulation Number
878.5020
EU market of registration
Germany
GUDID distribution status
In Commercial Distribution

Truth per registry

2 sources · 1 field differs

FieldEUDAMEDGUDID
Device ClassEUDAMED
Class IIb
GUDID
Class II

Manufacturer details

EUDAMED SRN
JP-MF-000017860
Authorised representative
Obelis s.a. BE-AR-000000106

Other devices from Mani, Inc.

See all devices from Mani, Inc. →

Properties

  • Sterile
  • Single Use
  • Implantable
  • Sutures
  • CMR Substance NoEUDAMEDYesEUDAMED
  • Prescription Use
  • Lot / Batch Number
  • Expiration Date
  • Manufacturing Date

Other properties (16)

  • Reusable: No
  • Contains Latex: No
  • Reprocessed: 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
  • Premarket Exempt: No
  • Serial Number: No