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Membrane Assembly 2258

by Medica Corp.

Membrane Assembly 2258 is a Class II device made by Medica Corp., cleared under FDA 510(k) K864872 on 13 Mar 1987 and listed in FDA GUDID since 4 Dec 2018 (UDI-DI 00386100003173), active as of 23 Oct 2026.

Active United States. Also listed in GUDID (US).

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 23 Oct 2026

Documents

510(k) K864872

FDA submission, from GUDID

Trust

Unverified

Source GUDID, synced 23 Oct 2026.

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number00386100003173 UDI-DI Date4 Dec 2018ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE from GUDID Substantially Equivalent · Traditional NumberK864872 Date13 Mar 1987DecidedStatusActive

Official records

Across registries

2 registries list this device

  • FDA 510(k) K864872 decided 13 Mar 1987 Active
  • FDA GUDID UDI-DI 00386100003173 listed 4 Dec 2018 Listed

Timeline

2 dated events

  1. Cleared FDA 510(k) K864872
  2. Listed FDA GUDID 00386100003173

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — FDA 510(k) Active

Specification

GUDID

Trade name
Membrane Assembly
Generic name
Reference electrode IVD
Model / Ref / Catalog
2258
Primary DI / UDI-DI
00386100003173
510(k) Number
FDA product code
CEM, JGS
GMDN term
Reference electrode IVD
Device class
Class II
Regulation number
862.1600, 862.1665
GUDID distribution status
In Commercial Distribution

Related devices

Category: Reference electrode IVD

Cleared under the same submission (K864872)

and 8 more cleared under K864872

Other devices from Medica Corp.

See all devices from Medica Corp. →

Properties

  • Prescription use
  • Lot / batch number
  • Manufacturing date
Other properties (12, all answered No)