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Humeca blade for Humby long knife (20cm/7.9 in)

by Humeca B.V.

Ref 5.BLHUL/1Model Humeca blades for Knives

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

CE MDR CE MDD

Valid until

1 Aug 2031

CE MDR certificate

FDA recalls

Not checked

No FDA submission to match recalls against

Documents

1 certificate

Certifier DEKRA Certification B.V.

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/MDR EUDAMED Number2269201CE01 Date3 Aug 2026IssuedStatusActive expires 1 Aug 2031
United StatesGUDID listing GUDID Number08717903490242 UDI-DI Date20 May 2025ListedStatusListed GUDID: in commercial distribution
European UnionCE/MDD EUDAMED NumberB-08717903490242 Basic UDI-DI 08717903490242UDI-DIDate5 Apr 2023RegisteredStatusActive

Certificates

1 certificate · EUDAMED

EUDAMED certificates (1)
  • 2269201CE01 Active

    Quality management system EU MDR

    Certifier
    DEKRA Certification B.V. 0344
    Issued
    3 Aug 2026
    Expires
    1 Aug 2031

Coverage

2 jurisdictions

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  • Withdrawn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

Specification

EUDAMED · GUDID

Trade Name
Humeca blade for Humby long knife EUDAMED
Humeca blade for Humby long knife (20cm/7.9 in) GUDID
Generic Name
Dermatome blade, single-use
Device Name
Humeca blades for Knives
Model / Ref / Catalog
5.BLHUL/1, Humeca blades for Knives
Primary DI / UDI-DI
08717903490242
Basic UDI-DI
B-08717903490242, 871790349KNVSBLVM
FDA Product Code
GES
EMDN Code
V010302 Blades without safety systems, single-use - not included in other classes
GMDN Term
Dermatome blade, single-use
Device Class
Class IIa EUDAMED
Class I GUDID
Regulation Number
878.4800
EU market of registration
Netherlands
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
NL-MF-000010933

Related devices

Category: Manual scalpel blade, single-use

Other devices from Humeca B.V.

See all devices from Humeca B.V. →

Properties

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

Other properties (19)

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