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Acra Clip 500-104

by Acra-Cut Inc

Ref 500-104

Acra Clip 500-104 is a device classified as Class IIa in the EU and Class II in the US made by Acra-Cut Inc, registered in EUDAMED on 6 Nov 2026 (Basic UDI-DI B-00810607000149), cleared under FDA 510(k) K944311 on 18 Nov 1994 and listed in FDA GUDID since 1 May 2017 (UDI-DI 00810607000149), active as of 7 Nov 2026.

Active European Union and United States. Also listed in GUDID (US).

CE MDD 510(k)

Valid until

No date given

CE: no date in EUDAMED. FDA: not time-limited

FDA recalls

None found

in data synced 7 Nov 2026

Documents

None linked in EUDAMED

A group certificate may exist

510(k) K944311

FDA submission, from GUDID

Trust

Unverified

Source EUDAMED, GUDID, synced 7 Nov 2026.

Regulatory status

as of registry sync 7 Nov 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDD EUDAMED NumberB-00810607000149 Basic UDI-DI 00810607000149UDI-DIDate6 Nov 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number00810607000149 UDI-DI Date1 May 2017ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE GUDID from GUDID Substantially Equivalent · Traditional NumberK944311 Date18 Nov 1994DecidedStatusActive

Official records

Across registries

3 registries list this device

  • EUDAMED Basic UDI-DI B-00810607000149 registered 6 Nov 2026 Active
  • FDA 510(k) K944311 decided 18 Nov 1994 Active
  • FDA GUDID UDI-DI 00810607000149 listed 1 May 2017 Listed

Timeline

3 dated events

  1. Cleared FDA 510(k) K944311
  2. Listed FDA GUDID 00810607000149
  3. Registered EUDAMED B-00810607000149

Coverage

2 jurisdictions

United States of AmericaSwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered
  • European Union CE/MDD Active
  • United States FDA 510(k) Active

Specification

EUDAMED · GUDID

Trade name
Acra Clip
Generic name
Scalp clip forceps
Device name
Disposable Scalp Clip
Model / Ref / Catalog
500-104
Primary DI / UDI-DI
00810607000149
Basic UDI-DI
B-00810607000149
510(k) Number
FDA product code
HBO
EMDN code
H02010201 Skin clips
GMDN term
Scalp clip forceps
Device class
Class IIa EUDAMED
Class II GUDID
Regulation number
882.4150
EU registration type
Legacy device (under a directive)
EU market of registration
Germany
GUDID distribution status
In Commercial Distribution
Sterilisation method
Ethylene Oxide

Truth per registry

2 sources · 2 fields differ

FieldEUDAMEDGUDID
Device classEUDAMED
Class IIa
GUDID
Class II
Sterilise before useEUDAMED
No
GUDID
Yes

Registry differences

EUDAMED and FDA GUDID describe the same product (same UDI-DI) and state different values:

  • Sterilise before use UDI-DI 00810607000149: EUDAMED states No, FDA GUDID states Yes.

Device class is stated on each registry's own scale: Class IIa in the EU (EUDAMED), Class II in the US (FDA GUDID). EU and US classes are different schemes, so this is not a disagreement.

Related devices

Category: Scalp clip forceps

Cleared under the same submission (K944311)

and 4 more cleared under K944311

Similar devices in this category

Other devices filed under SKIN STAPLERS.

Other devices from Acra-Cut Inc

See all devices from Acra-Cut Inc →

Properties

  • Supplied sterile
  • Sterilise before use NoEUDAMEDYesGUDID
  • Single use
  • Lot / batch number
  • Expiration date
Other properties (20, all answered No)