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Lyher

EUDAMED

Class IVD devices for self-testing (EU MDR)

Ref 303051Ref 303021901Ref ISY-402-40Model ISY-402-01; ISY-402-05; ISY-402-20; ISY-402-25; ISY-402-40Ref IHMP-502-25Model IHMP-502-01;IHMP-502-05; IHMP-502-20; IHMP-502-25; IHMP-502-40Ref ISY-402-01Ref IHMP-502-05Ref IAD-502-25Model IAD-502-01; IAD-502-05; IAD-502-20; IAD-502-25; IAD-502-40Ref IDE-B402-01Model IDE-B402-01; IDE-B402-05; IDE-B402-20; IDE-B402-25; IDE-B402-40Ref IHMP-502-40Ref ISY-401-25Model ISY-401-01;ISY-401-05; ISY-401-20; ISY-401-25; ISY-401-40Ref ISY-402-20Ref IDE-B402-05Ref 303041901Ref ICO-502-05Model ICO-502-01; ICO-502-05; ICO-502-20; ICO-502-25; ICO-502-40 Ref ISY-401-20Ref IRS-572Ref IDE-B402-25Ref IDE-A402-05Model IDE-A402-01; IDE-A402-05; IDE-A402-20; IDE-A402-25; IDE-A402-40Ref IDE-A402-40Ref ISY-401-01Ref ICO-502-01Ref IAD-502-01Ref IAD-502-40

by Hangzhou Laihe Biotech Co., Ltd.

Identity

Trade Name
LYHER EUDAMED
Device Name
COVID-19 and Influenza A/B Antigen Test Kit for self-testing EUDAMED
Respiratory multiple 4 in 1 test kit (FluA/FluB/COVID-19/RSV) EUDAMED
Syphilis Rapid Test EUDAMED
Human Metapneumovirus (hMPV) Test Kit EUDAMED
Adenovirus Antigen Test Kit EUDAMED
Dengue NS1 Antigen Test Kit (Colloidal Gold) EUDAMED
Respiratory multiple 7 in 1 test kit (FluA/FluB/COVID-19/RSV/Adeno/MP/HMPV) EUDAMED
Novel Coronavirus (COVID-19) Antigen Test Kit (Colloidal Gold) EUDAMED
Dengue IgG/IgM Test Kit (Colloidal Gold) EUDAMED
Model / Reference
303051 EUDAMED
303021901 EUDAMED
ISY-402-01; ISY-402-05; ISY-402-20; ISY-402-25; ISY-402-40 EUDAMED
ISY-402-40 EUDAMED
IHMP-502-01;IHMP-502-05; IHMP-502-20; IHMP-502-25; IHMP-502-40 EUDAMED
IHMP-502-25 EUDAMED
ISY-402-01 EUDAMED
IHMP-502-05 EUDAMED
IAD-502-01; IAD-502-05; IAD-502-20; IAD-502-25; IAD-502-40 EUDAMED
IAD-502-25 EUDAMED
IDE-B402-01; IDE-B402-05; IDE-B402-20; IDE-B402-25; IDE-B402-40 EUDAMED
IDE-B402-01 EUDAMED
IHMP-502-40 EUDAMED
ISY-401-01;ISY-401-05; ISY-401-20; ISY-401-25; ISY-401-40 EUDAMED
ISY-401-25 EUDAMED
ISY-402-20 EUDAMED
IDE-B402-05 EUDAMED
303041901 EUDAMED
ICO-502-01; ICO-502-05; ICO-502-20; ICO-502-25; ICO-502-40 EUDAMED
ICO-502-05 EUDAMED
ISY-401-20 EUDAMED
IRS-572 EUDAMED
IDE-B402-25 EUDAMED
IDE-A402-01; IDE-A402-05; IDE-A402-20; IDE-A402-25; IDE-A402-40 EUDAMED
IDE-A402-05 EUDAMED
IDE-A402-40 EUDAMED
ISY-401-01 EUDAMED
ICO-502-01 EUDAMED
IAD-502-01 EUDAMED
IAD-502-40 EUDAMED

Identifiers

Primary DI / UDI-DI
06972412611256 EUDAMED
06972412611515 EUDAMED
06972412611522 EUDAMED
06972412613311 EUDAMED
06972412611737 EUDAMED
06972412617494 EUDAMED
06972412615902 EUDAMED
06972412615773 EUDAMED
06972412613977 EUDAMED
06972412617722 EUDAMED
06972412612413 EUDAMED
06972412613984 EUDAMED
06972412616930 EUDAMED
06972412613823 EUDAMED
06972412616367 EUDAMED
06972412612260 EUDAMED
06972412614721 EUDAMED
06972412616725 EUDAMED
06972412618514 EUDAMED
06972412615872 EUDAMED
06972412619481 EUDAMED
06972412616206 EUDAMED
06972412611089 EUDAMED
06972412612673 EUDAMED
06972412617128 EUDAMED
Basic UDI-DI
B-06972412611256 EUDAMED
0697241261IRS-542BF EUDAMED
697241261ISY-402MB EUDAMED
697241261IHMP-502TL EUDAMED
697241261IAD-5026X EUDAMED
697241261IDE-B402ER EUDAMED
697241261ISY-401M9 EUDAMED
0697241261IRS-572BQ EUDAMED
697241261ICO-502BJ EUDAMED
697241261IDE-A402EJ EUDAMED
EMDN Code
W0105040519,W0105099004 EUDAMED
W0105090699 OTHER MULTIPLE PATHOGENS - RT & POC EUDAMED
W0105090105 SYPHILIS - RT & POC EUDAMED
W0105099099 VIROLOGY - RT & POC - OTHER EUDAMED
W0105099007 DENGUE - RT & POC EUDAMED
W0105090501 CORONAVIRUS ANTIGEN (AG) - RT & POC EUDAMED

Classification

Device Class
Class IVD devices for self-testing EUDAMED
Class B EUDAMED
Class C EUDAMED
Market of Registration
Netherlands EUDAMED
Spain EUDAMED

Clinical & Handling

Sterile

No

EUDAMED

Human Tissues

No

EUDAMED

Animal Tissues

Yes

EUDAMED

Microbial Substances

No

EUDAMEDEUDAMED

Reagent

Yes

EUDAMED

Self Testing

Yes

EUDAMEDEUDAMED

Near-Patient Testing

No

EUDAMED

Professional Testing

No

EUDAMEDEUDAMED

Companion Diagnostics

No

EUDAMED

Surgical Instrument

No

EUDAMED

New Device

No

EUDAMED

Lyher by Hangzhou Laihe Biotech Co., Ltd. — Class IVD devices for self-testing — IVDR, IVDD — listed in EUDAMED — regulatory data on deviCERTS

Authorization Coverage (European Union — 27 member states)

Regulatory Authorizations

European Union Active

CE/IVDR

European Union Active

CE/IVDD

Is this your device? Claim it to add documentation and request validation.

Manufacturer

Manufacturer
Hangzhou Laihe Biotech Co., Ltd.
EUDAMED SRN
CN-MF-000033566
Authorised Representative
SUNGO Europe B.V. NL-AR-000000247

Sources (25)

  • EUDAMED 07b262c2-bcfb-48d5-a5d8-6c062b0b903e 61 fields · synced Aug 4, 2026
  • EUDAMED 5de4a301-b026-4ad9-add4-09dd39358ca9 61 fields · synced May 17, 2026
  • EUDAMED cca96d92-cd8c-4c72-a5be-b334262113d4 61 fields · synced May 17, 2026
  • EUDAMED a1c8046e-389d-4e3b-915b-a5559a84ffbd 61 fields · synced Jul 8, 2026
  • EUDAMED 8ffcf20e-cb0c-45d7-9739-974db387d2a1 61 fields · synced Jul 9, 2026
  • EUDAMED 8e652eb4-69ad-44d9-b4cf-2ae1e96f0f65 61 fields · synced Jul 9, 2026
  • EUDAMED 96d0bac2-bda5-448d-993c-6a331b0fc839 61 fields · synced Jul 9, 2026
  • EUDAMED 90409f82-d6d3-480c-9dd5-0b9d5895a9ee 61 fields · synced Jul 9, 2026
  • EUDAMED 9e883d8b-2301-4e05-8c9c-edaae8ee5bba 61 fields · synced Jul 9, 2026
  • EUDAMED f830f99d-9d59-42e5-b8c7-755b2c35e016 61 fields · synced Jul 10, 2026
  • EUDAMED 8869238e-a3ac-4400-82fd-7d43fb0c33ed 61 fields · synced Jul 10, 2026
  • EUDAMED 97088b16-59a1-4dff-bbc1-a1ed6eb55245 61 fields · synced Jul 11, 2026
  • EUDAMED e94394fc-9ea4-49ec-8837-85084b68f418 61 fields · synced Jul 13, 2026
  • EUDAMED df7370c6-f7c0-44db-9b5f-2a45cba2cf3a 61 fields · synced Jul 15, 2026
  • EUDAMED 44587557-362b-43ea-9b6c-c7a0cecf6cbb 61 fields · synced Jul 16, 2026
  • EUDAMED bd9db3b4-5bbb-45a9-b747-6061291a0d86 61 fields · synced Jul 19, 2026
  • EUDAMED 4cd1a0a3-a433-4260-888b-9e158b13f8a0 61 fields · synced Jul 20, 2026
  • EUDAMED 86197b4b-6ad6-4a4a-85ed-632194a0707c 61 fields · synced Jul 21, 2026
  • EUDAMED 48af8053-9640-4426-8aba-a26bc2213987 61 fields · synced Jul 23, 2026
  • EUDAMED 59f1986a-e4fd-4e09-9ed7-0d0b99e38ec7 61 fields · synced Jul 24, 2026
  • EUDAMED 236d13da-17ba-476b-bf10-16ef81a3d633 61 fields · synced Jul 29, 2026
  • EUDAMED 03fc2154-ac93-4389-a5dc-832bc5e8b6f9 61 fields · synced Jul 29, 2026
  • EUDAMED 2c39bb0b-c26c-4676-b4ac-0da0680caa85 61 fields · synced Jul 31, 2026
  • EUDAMED c66725ec-645f-4401-a3bb-99a389fc6783 61 fields · synced Aug 3, 2026
  • EUDAMED d9ac5f98-4975-4c66-bbf2-9f7563a4510a 61 fields · synced Aug 4, 2026