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Breathing System Filter(HMEF)

by Hangzhou Tappa Medical Technology Co, Ltd. China EUDAMED

Ref HME215, HME103, HME211S, HME106S, HME207, HME201, HME205S, HME101S, HME202, HME210, HME212, HME217S, HME204, HME213S, HME305S, HME216S, HME105S, HME211, HME101, HME301S, HME206, HME208S, HME102S, HME105, HME303, HME102, HME106, HME212S, HME104, HME213, HME303S, HME104S, HME205, HME103S, HME208

EMDN R040299

Regulatory status

as of 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR NumberB-HME215AU Basic UDI-DIDate27 Oct 2022RegisteredStatusActive
European UnionCE/MDD NumberB-HME215AU Basic UDI-DIDate27 Oct 2022RegisteredStatusActive

Coverage

1 jurisdiction

SwedenFinlandFinlandSwedenFinlandFinlandSwedenSwedenLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyGermanyPolandPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaPolandFranceFranceAustriaHungaryRomaniaFranceFranceSloveniaBulgariaPortugalSpainSpainItalySpainSpainCroatiaGreeceMaltaCyprus
  • Active
  • Not covered

European Union — CE/MDR, CE/MDD Active

Certificates: none listed in EUDAMED

Specification

EUDAMED · synced 22 Oct 2026

Model / Reference
HME215, HME103, HME211S, HME106S, HME207, HME201, HME205S, HME101S, HME202, HME210, HME212, HME217S, HME204, HME213S, HME305S, HME216S, HME105S, HME211, HME101, HME301S, HME206, HME208S, HME102S, HME105, HME303, HME102, HME106, HME212S, HME104, HME213, HME303S, HME104S, HME205, HME103S, HME208
Primary DI / UDI-DI
D-HME215AU, D-HME103AG, D-HME211SSY, D-HME106ST3, D-HME207AV, D-HME201AH, D-HME205ST7, D-HME101SSL, D-HME202AK, D-HME210AJ, D-HME212AN, D-HME217STJ, D-HME204AP, D-HME213ST6, D-HME305STE, D-HME216STF, D-HME105SSY, D-HME211AL, D-HME101AC, D-HME301ST2, D-HME206AT, D-HME208STG, D-HME102SSP, D-HME105AL, D-HME303AS, D-HME102AE, D-HME106AN, D-HME212ST3, D-HME104AJ, D-HME213AQ, D-HME303ST8, D-HME104SSV, D-HME205AR, D-HME103SSS, D-HME208AX, 06950456305775, 06950456305911, 06950456305768, 06950456305881, 06950456305744, 06950456305966
Basic UDI-DI
B-HME215AU, B-HME103AG, B-HME211SSY, B-HME106ST3, B-HME207AV, B-HME201AH, B-HME205ST7, B-HME101SSL, B-HME202AK, B-HME210AJ, B-HME212AN, B-HME217STJ, B-HME204AP, B-HME213ST6, B-HME305STE, B-HME216STF, B-HME105SSY, B-HME211AL, B-HME101AC, B-HME301ST2, B-HME206AT, B-HME208STG, B-HME102SSP, B-HME105AL, B-HME303AS, B-HME102AE, B-HME106AN, B-HME212ST3, B-HME104AJ, B-HME213AQ, B-HME303ST8, B-HME104SSV, B-HME205AR, B-HME103SSS, B-HME208AX, 69504563HME38
EMDN Code
R040299 Natural breathing filters - other
Device Class
Class IIa
Market of Registration
Germany

Manufacturer details

EUDAMED SRN
CN-MF-000027753
Authorised representative
Prolinx GmbH DE-AR-000005129

Other devices from Hangzhou Tappa Medical Technology Co., Ltd.

See all devices from Hangzhou Tappa Medical Technology Co., Ltd. →

Properties & raw data

Show properties, registry sources and raw records
  • Sterile
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

Sources (41)

  • EUDAMED adae79c9-8518-478f-9492-4129155e3b4c 61 fields · synced 22 Oct 2026
  • EUDAMED D-HME103AG|B-HME103AG 61 fields · synced 11 May 2026
  • EUDAMED D-HME211SSY|B-HME211SSY 61 fields · synced 11 May 2026
  • EUDAMED D-HME106ST3|B-HME106ST3 61 fields · synced 16 May 2026
  • EUDAMED D-HME207AV|B-HME207AV 61 fields · synced 16 May 2026
  • EUDAMED D-HME201AH|B-HME201AH 61 fields · synced 16 May 2026
  • EUDAMED D-HME205ST7|B-HME205ST7 61 fields · synced 16 May 2026
  • EUDAMED D-HME101SSL|B-HME101SSL 61 fields · synced 17 May 2026
  • EUDAMED D-HME202AK|B-HME202AK 61 fields · synced 17 May 2026
  • EUDAMED D-HME210AJ|B-HME210AJ 61 fields · synced 17 May 2026
  • EUDAMED D-HME212AN|B-HME212AN 61 fields · synced 17 May 2026
  • EUDAMED D-HME217STJ|B-HME217STJ 61 fields · synced 17 May 2026
  • EUDAMED D-HME204AP|B-HME204AP 61 fields · synced 17 May 2026
  • EUDAMED D-HME213ST6|B-HME213ST6 61 fields · synced 17 May 2026
  • EUDAMED D-HME305STE|B-HME305STE 61 fields · synced 17 May 2026
  • EUDAMED D-HME216STF|B-HME216STF 61 fields · synced 17 May 2026
  • EUDAMED D-HME105SSY|B-HME105SSY 61 fields · synced 17 May 2026
  • EUDAMED D-HME211AL|B-HME211AL 61 fields · synced 17 May 2026
  • EUDAMED D-HME101AC|B-HME101AC 61 fields · synced 18 May 2026
  • EUDAMED D-HME301ST2|B-HME301ST2 61 fields · synced 18 May 2026
  • EUDAMED D-HME206AT|B-HME206AT 61 fields · synced 18 May 2026
  • EUDAMED D-HME208STG|B-HME208STG 61 fields · synced 18 May 2026
  • EUDAMED D-HME102SSP|B-HME102SSP 61 fields · synced 18 May 2026
  • EUDAMED D-HME105AL|B-HME105AL 61 fields · synced 18 May 2026
  • EUDAMED D-HME303AS|B-HME303AS 61 fields · synced 18 May 2026
  • EUDAMED D-HME102AE|B-HME102AE 61 fields · synced 18 May 2026
  • EUDAMED D-HME106AN|B-HME106AN 61 fields · synced 18 May 2026
  • EUDAMED D-HME212ST3|B-HME212ST3 61 fields · synced 18 May 2026
  • EUDAMED D-HME104AJ|B-HME104AJ 61 fields · synced 18 May 2026
  • EUDAMED D-HME213AQ|B-HME213AQ 61 fields · synced 18 May 2026
  • EUDAMED D-HME303ST8|B-HME303ST8 61 fields · synced 18 May 2026
  • EUDAMED D-HME104SSV|B-HME104SSV 61 fields · synced 18 May 2026
  • EUDAMED D-HME205AR|B-HME205AR 61 fields · synced 19 May 2026
  • EUDAMED D-HME103SSS|B-HME103SSS 61 fields · synced 19 May 2026
  • EUDAMED D-HME208AX|B-HME208AX 61 fields · synced 19 May 2026
  • EUDAMED 06950456305775|69504563HME38 61 fields · synced 7 Oct 2026
  • EUDAMED 06950456305911|69504563HME38 61 fields · synced 7 Oct 2026
  • EUDAMED 06950456305768|69504563HME38 61 fields · synced 7 Oct 2026
  • EUDAMED 06950456305881|69504563HME38 61 fields · synced 8 Oct 2026
  • EUDAMED 06950456305744|69504563HME38 61 fields · synced 8 Oct 2026
  • EUDAMED 06950456305966|69504563HME38 61 fields · synced 10 Oct 2026