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Lympha Press

by Mego Afek AC Ltd. EUDAMED510(k)GUDID

Active United States and European Union

Ref L1000229G, L10015G3, L41L0175L, L42L0FLL, L42L0FLR, L42L0FSL, L41LS175R, L41LM175R, L4132085, L4132095, L41111C2, L4132075, L4134075, L41111C1Model 201ET, 731A, JKTAT, FL, ARM510(k) K182003

Regulatory status

as of 27 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number729010587201ETST Basic UDI-DIDate27 Apr 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number07290105879608 UDI-DIDate24 Dec 2019ListedStatusIn distribution
United StatesFDA 510(k)SESE 510(k) Substantially Equivalent · Traditional NumberK182003 Date27 Feb 2019ClearedStatusActive

Coverage

2 jurisdictions

United States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaSwedenFinlandFinlandUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaSwedenFinlandFinlandUnited States of AmericaUnited States of AmericaUnited States of AmericaSwedenSwedenLatviaEstoniaUnited States of AmericaDenmarkLithuaniaIrelandNetherlandsGermanyGermanyPolandPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaPolandUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaFranceFranceAustriaHungaryRomaniaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaFranceFranceSloveniaBulgariaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaPortugalSpainSpainItalyUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaSpainSpainCroatiaGreeceUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaMaltaCyprusUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not known
  • Not covered
  • United States FDA 510(k) Active
  • European Union CE/MDR Active

Recalls: none on record (FDA, checked 24 Oct 2026)

Certificates: none listed in EUDAMED

Specification

EUDAMED · 510(k) · GUDID

Trade Name
Lympha Press EUDAMED
Left Arm and Torso NRC-JKT GUDID
ComfySleeve 1-75 S-Right NRC-JKT GUDID
FL sleeve 4-75 RC-FLS GUDID
FL sleeve 2-85 RC-FLS GUDID
FL sleeve 2-75 RC-FLS GUDID
ComfySleeve 1-75 M-Right NRC-JKT GUDID
Generic Name
Multi-chamber venous compression system garment, reusable
Device Name
Lympha Press Mini
Lympha Press PCD-51
FL Leg Sleeve
LP12 Arm W/Shoulder S
Model / Ref / Catalog
201ET, L1000229G, 731A, L10015G3, JKTAT, L41L0175L, L42L0FLL, L42L0FLR, L42L0FSL, L41LS175R, L41LM175R, FL, L4132085, L4132095, ARM, L41111C2, L4132075, L4134075, L41111C1, Comfy 1-75 Left, Comfy 1-75 S Right, FL 4-75, FL 2-85, FL 2-75, Comfy 1-75 M Right
Primary DI / UDI-DI
07290105879608, 07290105879370, 07290105875624, 07290105873552, 07290105872913, 07290105872807, 07290105872791, 07290105873538, 07290105873842, 07290105873859, 07290105873880, 07290105876072, 07290105876430, 07290105877291
Basic UDI-DI
729010587201ETST, 729010587731A38, 729010587JKTATDF, 729010587FLT2, 729010587ARMJS
Direct Marketing DI
07290105879608
07290105879370
510(k) Number
FDA Product Code
JOW
EMDN Code
Z120607 Pneumatic compression equipment
GMDN Term
Multi-chamber venous compression system garment, reusable
Device Class
Class IIa EUDAMED
Class I EUDAMED
Class II 510(k)GUDID
Regulation
21 CFR Part 870.5800
Market of Registration
Germany
Italy
Norway
Denmark
Advisory Committee
Cardiovascular
FDA Decision
SESE Substantially Equivalent
Commercial Distribution
In Commercial Distribution

Truth per registry

3 sources · 3 fields differ

FieldEUDAMED510(k)GUDID
Model / ReferenceEUDAMED
201ET
L1000229G
731A
L10015G3
JKTAT
L41L0175L
L42L0FLL
L42L0FLR
L42L0FSL
L41LS175R
L41LM175R
FL
L4132085
L4132095
ARM
L41111C2
L4132075
L4134075
L41111C1
510(k)
n/a
GUDID
Comfy 1-75 Left
Comfy 1-75 S Right
FL 4-75
FL 2-85
FL 2-75
Comfy 1-75 M Right
510(k) NumberEUDAMED
n/a
510(k)
K182003
GUDID
K100521
K013331
Device ClassEUDAMED
Class IIa
Class I
510(k)
Class II
GUDID
Class II

Manufacturer details

EUDAMED SRN
IL-MF-000006982
Authorised representative
MedNet EC-REP GmbH DE-AR-000000002

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Properties

  • Prescription Use
  • Serial Number
  • Manufacturing Date

Other properties (21)

  • 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
  • Over-the-Counter: No
  • Convenience Kit: No
  • Combination Product: No
  • HCT/P: No
  • Premarket Exempt: No
  • Lot / Batch Number: No
  • Expiration Date: No