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Mani Sutures Silk - 9-0 Silk

by Mani, Inc. 7 variants

Ref 1413S

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

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 25 Oct 2026. What this means

Regulatory status

as of registry sync 25 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDD EUDAMED NumberB-04546951401405 Basic UDI-DIDate13 Nov 2025RegisteredStatusActive
United StatesGUDID listing GUDID Number04546951401405 UDI-DIDate4 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  • Withdrawn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/MDD Active
  • United States GUDID listing Listed

Specification

EUDAMED · GUDID

Trade Name
Mani Sutures Silk - 9-0 Silk EUDAMED
MANI Sutures Silk GUDID
Generic Name
Silk suture
Model / Ref / Catalog
1413S
Primary DI / UDI-DI
04546951401405, 04546951633745
Basic UDI-DI
B-04546951401405, 4546951000004ZF
FDA Product Code
GAP
EMDN Code
H010202020301 Silk with needle
GMDN Term
Silk suture
Device Class
Class IIb EUDAMED
Class II GUDID
Regulation Number
878.5030
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