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Fine Microrasp 7.5x5mm

by Bien-Air Surgery SA EUDAMEDGUDID

Active European Union

Ref 1503126Model Maxillofacial Microsaw Blades

Regulatory status

as of 28 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number76300555_029_FS Basic UDI-DIDate18 Sep 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number17630055518009 UDI-DIDate30 Mar 2026ListedStatusListed GUDID: not in commercial distribution

Coverage

2 jurisdictions

United States of AmericaSwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered
  • European Union CE/MDR Active
  • United States GUDID listing Listed

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.

Recalls

0 recalls · FDA

No FDA recalls on record, checked 23 Oct 2026.

Specification

EUDAMED · GUDID

Generic Name
Surgical saw blade, reciprocating, single-use
Model / Reference
Maxillofacial Microsaw Blades, 1503126
Primary DI / UDI-DI
17630055518009
Basic UDI-DI
76300555_029_FS
FDA Product Code
GFA
EMDN Code
Q010399 Surgical dental devices - other
GMDN Term
Surgical saw blade, reciprocating, single-use
Device Class
Class IIa EUDAMED
Class I GUDID
Regulation Number
878.4820
Market of Registration
France
GUDID distribution status
Not in Commercial Distribution

Truth per registry

2 sources · 1 field differs

FieldEUDAMEDGUDID
Device ClassEUDAMED
Class IIa
GUDID
Class I

Manufacturer details

EUDAMED SRN
CH-MF-000016376
Authorised representative
Bien-Air Europe Sàrl FR-AR-000011942

Other devices from Bien-Air Surgery SA

See all devices from Bien-Air Surgery SA →

Properties

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

Other properties (17)

  • Implantable: No
  • Reusable: 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