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Biomet Biologics

by Micromedics, Inc. 6 variants

Ref 800-0201

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 24 Oct 2026. What this means

Regulatory status

as of registry sync 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDD EUDAMED NumberB-10815634021416 Basic UDI-DI Date31 Mar 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number10815634021416 UDI-DI Date2 Nov 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  • Withdrawn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
Biomet Biologics EUDAMED
FibriJet GUDID
Generic Name
Open-surgery adhesive/sealant applicator, dual-channel
Device Name
Applicator Tip
800-0201
Model / Reference
800-0201
Primary DI / UDI-DI
10815634021416, 00815634021419, 20815634021413
Basic UDI-DI
B-10815634021416, B-00815634021419, B-20815634021413
FDA Product Code
KYZ
EMDN Code
A020199 Syringes, single-use - other
GMDN Term
Open-surgery adhesive/sealant applicator, dual-channel
Device Class
Class IIa EUDAMED
Class I GUDID
Regulation Number
880.6960
EU market of registration
Belgium
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
US-MF-000018365
Authorised representative
MDSS GmbH DE-AR-000005430

Other devices from Micromedics, Inc.

See all devices from Micromedics, Inc. →

Properties

  • Sterile
  • Single Use
  • Prescription Use
  • Lot / Batch Number
  • Expiration Date
  • Manufacturing Date

Other properties (16)

  • Implantable: No
  • Reusable: No
  • Contains Latex: No
  • Reprocessed: No
  • Human-derived: No
  • Human Tissues: No
  • Animal Tissues: 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