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Carilex

by Carilex Medical, Inc 8 variants

Ref S2202-2010, S2101-2420, S2602-7060, S2302-2050, S1002-0072, S2202-2350, S2001-2570, S2809-2020, S2003-2110, S1002-3022, S2202-0058, S2203-2200, S2202-2500, S1001-6140, S2302-2040, S1001-0042, S2202-2050, S2202-3011, S1002-3042V, S2809-2010, S2001-2600, S2103-2010, S2001-2690, S2305-3012, S2002-3115, S2102-3035, S2102-2160, S2101-2320, S2101-2410, S2602-2090, S2303-5030, S2101-2330, S2005-3017, S2809-0025, S2809-0015, S2302-2010, S2202-2330, S2302-5010, S2101-2300, S2004-3068, S2202-3081, S1001-2150, S2202-2510, S2202-2290, S2004-3053, S2102-2020, S2301-3103, S2003-2170, S2005-3058, S1004-3022, S2001-2630Model TheraFlo AP

Active European Union

CE MDR

Valid until

Not listed

EUDAMED holds no validity date

FDA recalls

Not applicable

No FDA record for this device

Documents

None linked in EUDAMED

A group certificate may exist

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source EUDAMED, synced 23 Oct 2026. What this means

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number471987369S2XXXS4 Basic UDI-DI Date4 Feb 2023RegisteredStatusActive

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

1 jurisdiction

SwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

European Union — CE/MDR Active

Specification

EUDAMED

Device Name
Anti-decubitus Air Alternating Pressure Device and System with Accessories
Negative Pressure Wound Therapy System
Negative Pressure Wound Therapy System (Dressing Kit)
Model / Reference
TheraFlo AP, S2202-2010, S2101-2420, S2602-7060, S2302-2050, S1002-0072, S2202-2350, S2001-2570, S2809-2020, S2003-2110, S1002-3022, S2202-0058, S2203-2200, S2202-2500, S1001-6140, S2302-2040, S1001-0042, S2202-2050, S2202-3011, S1002-3042V, S2809-2010, S2001-2600, S2103-2010, S2001-2690, S2305-3012, S2002-3115, S2102-3035, S2102-2160, S2101-2320, S2101-2410, S2602-2090, S2303-5030, S2101-2330, S2005-3017, S2809-0025, S2809-0015, S2302-2010, S2202-2330, S2302-5010, S2101-2300, S2004-3068, S2202-3081, S1001-2150, S2202-2510, S2202-2290, S2004-3053, S2102-2020, S2301-3103, S2003-2170, S2005-3058, S1004-3022, S2001-2630
Primary DI / UDI-DI
04713616090612, 04719873695942, 04719873694136, 04713616094795, 04719873695904, 04719873694716, 04719873690947, 04719873693245, 04719873692569, 04719873696765, 04713616094832, 04719873691623, 04713616091756, 04719873695560, 04713616092135, 04719873692132, 04713616094887, 04719873691838, 04719873696727, 04713616096164, 04719873692927, 04713616094269, 04719873692996, 04719873698066, 04719873692026, 04713616090551, 04719873692248, 04719873693313, 04719873695713, 04713616091947, 04719873692781, 04719873693320, 04719873694914, 04719873693221, 04713616096157, 04713616099059, 04719873694822, 04719873696390, 04719873693290, 04713616091862, 04713616093774, 04713616091411, 04713616091992, 04719873694297, 04713616091855, 04713616094191, 04719873691517, 04719873696888, 04713616094757, 04719873696789, 04719873692941
Basic UDI-DI
471987369S2XXXS4, 471361609S2XXXCR, 471987369S1XXXRV, 471361609S1XXXCJ
Direct Marketing DI
04713616090612
04719873695942
04719873694136
04713616094795
04719873695904
04719873694716
04719873690947
04719873693245
04719873692569
04719873696765
04713616094832
04719873691623
04713616091756
04713616092135
04719873692132
04713616094887
04719873691838
04719873696727
04713616096164
04719873692927
04713616094269
04719873692996
04719873698066
04719873692026
04713616090551
04719873692248
04719873693313
04719873695713
04713616091947
04719873692781
04719873693320
04719873694914
04719873693221
04713616096157
04713616099059
04719873694822
04719873696390
04719873693290
04713616091862
04713616093774
04713616091992
04719873694297
04713616091855
04713616094191
04719873691517
04719873696888
04713616094757
04719873696789
04719873692941
EMDN Code
V080701, Z12019003, A0680, M040499
Device Class
Class IIa
Class I
Class IIb
EU market of registration
Italy
Germany
Czechia

Manufacturer details

EUDAMED SRN
TW-MF-000002145
Authorised representative
Emergo Europe B.V. NL-AR-000000116

Other devices from Carilex Medical, Inc.

See all devices from Carilex Medical, Inc. →

Properties

  • Sterile NoEUDAMEDYesEUDAMED

Other properties (12)

  • 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