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ActivaScrew™ Cannulated

by Bioretec Ltd. EUDAMEDGUDID

Active European Union

Ref B-ASC-4540

Regulatory status

as of 29 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing GUDID Number06438394001671 UDI-DIDate5 Feb 2026ListedStatusListed GUDID: in commercial distribution
European UnionCE/MDD EUDAMED NumberB-06438394001671 Basic UDI-DIDate3 Dec 2021RegisteredStatusActive

Coverage

2 jurisdictions

United States of AmericaSwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered
  • European Union CE/MDD 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 22 Oct 2026.

Specification

EUDAMED · GUDID

Trade Name
ActivaScrew™ Cannulated EUDAMED
ActivaScrew™ GUDID
Generic Name
Bioabsorbable orthopaedic bone screw
Model / Ref / Catalog
B-ASC-4540
Primary DI / UDI-DI
06438394001671
Basic UDI-DI
B-06438394001671
510(k) Number
FDA Product Code
HWC
EMDN Code
P09120606 Osteosynthesis devices, biodegradable screws and bars
GMDN Term
Bioabsorbable orthopaedic bone screw
Device Class
Class III EUDAMED
Class II GUDID
Regulation Number
888.3040
Market of Registration
Finland
GUDID distribution status
In Commercial Distribution
MRI Safety
MR Safe
Size
Width — 4.5 Millimeter
Length — 40 Millimeter

Truth per registry

2 sources · 1 field differs

FieldEUDAMEDGUDID
Device ClassEUDAMED
Class III
GUDID
Class II

Manufacturer details

EUDAMED SRN
FI-MF-000001328

Other devices from Bioretec Ltd.

See all devices from Bioretec Ltd. →

Properties

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

Other properties (15)

  • 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