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1PLY W/Sewn Hole SZ B, 0 LNGTH 16-20

by Alps South, LLC

Ref CB1HNRG2

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

CE MDR

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 25 Oct 2026. What this means

Regulatory status

as of registry sync 25 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing GUDID Number00713980000365 UDI-DI Date30 Dec 2024ListedStatusListed GUDID: in commercial distribution
European UnionCE/MDR EUDAMED Number07139801000300177 Basic UDI-DI 00713980000365UDI-DIDate16 Feb 2024RegisteredStatusActive EUDAMED: not on the EU market

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  • Withdrawn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/MDR Active
  • United States GUDID listing Listed

Specification

EUDAMED · GUDID

Trade Name
1PLY W/Sewn Hole SZ B, 0 LNGTH 16-20 EUDAMED
Coolblue Sock GUDID
Generic Name
Stump sock
Model / Reference
CB1HNRG2
Primary DI / UDI-DI
00713980000365
Basic UDI-DI
07139801000300177
FDA Product Code
IPM
EMDN Code
Y090327 Socks for prostheses
GMDN Term
Stump sock
Device Class
Class I
Regulation Number
890.3025
GUDID distribution status
In Commercial Distribution

Manufacturer details

EUDAMED SRN
US-MF-000001260
Authorised representative
AR Experts B.V. NL-AR-000023989

Other devices from Alps South, LLC

See all devices from Alps South, LLC →

Properties

  • Premarket Exempt
  • Lot / Batch Number

Other properties (22)

  • Sterile: No
  • Single Use: No
  • 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
  • Expiration Date: No
  • Manufacturing Date: No