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MANI OPHTHALMIC KNIFE - Slit-Angled 3.5mm

by Mani, Inc.

Ref MSL35

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 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDD EUDAMED NumberB-04546951400118 Basic UDI-DI Date19 Nov 2025RegisteredStatusActive
United StatesGUDID listing GUDID Number04546951400118 UDI-DI Date16 Sep 2022ListedStatusListed 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  • Withdrawn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 OPHTHALMIC KNIFE - Slit-Angled 3.5mm EUDAMED
MANI Ophthalmic Knife GUDID
Generic Name
Ophthalmic knife, single-use
Model / Reference
MSL35 EUDAMED
MSL35 Slit-Angled 3.5mm GUDID
Primary DI / UDI-DI
04546951400118, 14546951400115
Basic UDI-DI
B-04546951400118, 4546951000011ZC
Unit of Use DI
74546951400117
FDA Product Code
HNN
EMDN Code
Q02010102 Ophthalmic microknives, angled
GMDN Term
Ophthalmic knife, single-use
Device Class
Class IIa EUDAMED
Class I GUDID
Regulation Number
886.4350
EU market of registration
Germany
GUDID distribution status
In Commercial Distribution

Truth per registry

2 sources · 2 fields differ

FieldEUDAMEDGUDID
Model / ReferenceEUDAMED
MSL35
GUDID
MSL35 Slit-Angled 3.5mm
Device ClassEUDAMED
Class IIa
GUDID
Class I

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
  • CMR Substance NoEUDAMEDYesEUDAMED
  • Premarket Exempt
  • Lot / Batch Number
  • Expiration Date
  • Manufacturing Date

Other properties (17)

  • Implantable: No
  • 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
  • Prescription Use: No
  • Over-the-Counter: No
  • Convenience Kit: No
  • Combination Product: No
  • HCT/P: No
  • Serial Number: No