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Codman® Holter® 821632

by Integra LifeSciences Production Corporation

Ref 82-1632Model 821632

Codman® Holter® 821632 (82-1632) is a device classified as Class III in the EU and Class II in the US made by Integra LifeSciences Production Corporation, registered in EUDAMED on 11 Sep 2026 (Basic UDI-DI B-10381780517818) and listed in FDA GUDID since 28 Feb 2020 (UDI-DI 10381780517818), active as of 23 Oct 2026.

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

CE MDD

Valid until

No date given

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

Source EUDAMED, GUDID, synced 23 Oct 2026.

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDD EUDAMED NumberB-10381780517818 Basic UDI-DI 10381780517818UDI-DIDate11 Sep 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number10381780517818 UDI-DI Date28 Feb 2020ListedStatusListed GUDID: in commercial distribution

Official records

Across registries

2 registries list this device

  • EUDAMED Basic UDI-DI B-10381780517818 registered 11 Sep 2026 Active
  • FDA GUDID UDI-DI 10381780517818 listed 28 Feb 2020 Listed

Timeline

2 dated events

  1. Listed FDA GUDID 10381780517818
  2. Registered EUDAMED B-10381780517818

Coverage

2 jurisdictions

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  • Withdrawn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

Specification

EUDAMED · GUDID

Trade name
Codman® Holter®
Generic name
Cranial port/reservoir
Model / Ref / Catalog
821632, 82-1632
Primary DI / UDI-DI
10381780517818
Basic UDI-DI
B-10381780517818
FDA product code
JXG
EMDN code
N01038099 Intracranial drainage devices and kits - accessories - other
GMDN term
Cranial port/reservoir
Device class
Class III EUDAMED
Class II GUDID
Regulation number
882.5550
EU registration type
Legacy device (under a directive)
EU market of registration
Belgium
GUDID distribution status
In Commercial Distribution
MRI safety
MR Conditional
Size
Length — 4 Centimeter

Truth per registry

2 sources · 1 field differs

FieldEUDAMEDGUDID
Device classEUDAMED
Class III
GUDID
Class II

Device class is stated on each registry's own scale: Class III 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: Cranial port/reservoir

Similar devices

Also classified as Cranial port/reservoir.

Similar devices in this category

Other devices filed under INTRACRANIAL DRAINAGE DEVICES AND KITS - ACCESSORIES - OTHER.

Other devices from Integra LifeSciences Production Corporation

See all devices from Integra LifeSciences Production Corporation →

Properties

  • Supplied sterile
  • Single use
  • Implantable
  • Prescription use
  • Lot / batch number
  • Expiration date
  • Manufacturing date
Other properties (18, all answered No)