Public EUDAMED Search

EUDAMED Device Search

A readable public search layer for EUDAMED device, manufacturer, UDI, EMDN and risk class data.

Last updated

22.09.2026 01:15

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Device

3431596

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Certificate

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Active filter:EMDN:W0102160199

237 device results listed.

Page 7 / 12

IVD Class CIVDR 2017/746On the marketDirect markingKitProfessional testingReagentSelf testingSingle use
Manufacturer
Xiamen Boson Biotech Co., Ltd.
Manufacturer SRN
CN-MF-000001096
UDI-DI
06921963721549
Basic UDI-DI
692196371613J5
Reference
1M01C4-2-CE
EMDN
W0102160199
EMDN description
SPECIFIC PROTEINS RT & POC - OTHER
First on market country
-
Safety summary (SSCP/SSP)
RR1M01040-R · Rev. 6.0
Authorised representative
Lotus NL B.V.
Last updated
17.07.2026 07:31
IVD Class CIVDR 2017/746On the marketDirect markingKitProfessional testingReagentSelf testingSingle use
Manufacturer
Xiamen Boson Biotech Co., Ltd.
Manufacturer SRN
CN-MF-000001096
UDI-DI
06921963721556
Basic UDI-DI
692196371613J5
Reference
1M01C4-B2-CE
EMDN
W0102160199
EMDN description
SPECIFIC PROTEINS RT & POC - OTHER
First on market country
-
Safety summary (SSCP/SSP)
RR1M01040-R · Rev. 6.0
Authorised representative
Lotus NL B.V.
Last updated
17.07.2026 07:31
IVD Class CIVDR 2017/746On the marketDirect markingKitProfessional testingReagentSelf testingSingle use
Manufacturer
Xiamen Boson Biotech Co., Ltd.
Manufacturer SRN
CN-MF-000001096
UDI-DI
06921963721563
Basic UDI-DI
692196371613J5
Reference
1M01C4-2-CE
EMDN
W0102160199
EMDN description
SPECIFIC PROTEINS RT & POC - OTHER
First on market country
-
Safety summary (SSCP/SSP)
RR1M01040-R · Rev. 6.0
Authorised representative
Lotus NL B.V.
Last updated
17.07.2026 07:31
IVD Class CIVDR 2017/746On the marketDirect markingKitProfessional testingReagentSelf testingSingle use
Manufacturer
Xiamen Boson Biotech Co., Ltd.
Manufacturer SRN
CN-MF-000001096
UDI-DI
06921963721570
Basic UDI-DI
692196371613J5
Reference
1M01C4-B2-CE
EMDN
W0102160199
EMDN description
SPECIFIC PROTEINS RT & POC - OTHER
First on market country
-
Safety summary (SSCP/SSP)
RR1M01040-R · Rev. 6.0
Authorised representative
Lotus NL B.V.
Last updated
17.07.2026 07:31
IVD Class CIVDR 2017/746On the marketDirect markingKitProfessional testingReagentSelf testingSingle use
Manufacturer
Xiamen Boson Biotech Co., Ltd.
Manufacturer SRN
CN-MF-000001096
UDI-DI
06921963721587
Basic UDI-DI
692196371613J5
Reference
1M01C4-2-CE
EMDN
W0102160199
EMDN description
SPECIFIC PROTEINS RT & POC - OTHER
First on market country
-
Safety summary (SSCP/SSP)
RR1M01040-R · Rev. 6.0
Authorised representative
Lotus NL B.V.
Last updated
17.07.2026 07:31
IVD Class CIVDR 2017/746On the marketDirect markingKitProfessional testingReagentSelf testingSingle use
Manufacturer
Xiamen Boson Biotech Co., Ltd.
Manufacturer SRN
CN-MF-000001096
UDI-DI
06921963721594
Basic UDI-DI
692196371613J5
Reference
1M01C4-B2-CE
EMDN
W0102160199
EMDN description
SPECIFIC PROTEINS RT & POC - OTHER
First on market country
-
Safety summary (SSCP/SSP)
RR1M01040-R · Rev. 6.0
Authorised representative
Lotus NL B.V.
Last updated
17.07.2026 07:31
IVD Class CIVDR 2017/746On the marketDirect markingKitProfessional testingReagentSelf testingSingle use
Manufacturer
Xiamen Boson Biotech Co., Ltd.
Manufacturer SRN
CN-MF-000001096
UDI-DI
06921963721600
Basic UDI-DI
692196371613J5
Reference
1M01C4-2-CE
EMDN
W0102160199
EMDN description
SPECIFIC PROTEINS RT & POC - OTHER
First on market country
-
Safety summary (SSCP/SSP)
RR1M01040-R · Rev. 6.0
Authorised representative
Lotus NL B.V.
Last updated
17.07.2026 07:31
IVD generalIVDDOn the marketKitNear-patient testingProfessional testingReagentSingle use
Manufacturer
Wuxi Biohermes Bio & Medical Technology Co., Ltd.
Manufacturer SRN
CN-MF-000014455
UDI-DI
D-CNMF000014455-BF-S223RM
Basic UDI-DI
B-CNMF000014455-BF-S223RM
Reference
BF-S223
EMDN
W0102160199
EMDN description
SPECIFIC PROTEINS RT & POC - OTHER
First on market country
Italy
Authorised representative
CMC Medical Devices & Drugs SL
Last updated
17.07.2026 04:52
Phosphorylated Tau-217 Protein Rapid Test

Phosphorylated Tau-217 Protein Rapid Test

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagentSingle use
Manufacturer
SAFECARE BIOTECH (HANGZHOU) CO., LTD.
Manufacturer SRN
CN-MF-000019109
UDI-DI
D-697424646Tau217000AZPW
Basic UDI-DI
B-697424646Tau217000AZPW
Reference
Tau217-4011/Tau217-3011/Tau217-4012/Tau217-3012
EMDN
W0102160199
EMDN description
SPECIFIC PROTEINS RT & POC - OTHER
First on market country
Germany
Authorised representative
Share info GmbH
Last updated
17.07.2026 04:16
Phosphorylated Tau-181 Protein Rapid Test

Phosphorylated Tau-181 Protein Rapid Test

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagentSingle use
Manufacturer
SAFECARE BIOTECH (HANGZHOU) CO., LTD.
Manufacturer SRN
CN-MF-000019109
UDI-DI
D-697424646Tau181000BPQ3
Basic UDI-DI
B-697424646Tau181000BPQ3
Reference
Tau181-4011/Tau181-3011/Tau181-4012/Tau181-3012
EMDN
W0102160199
EMDN description
SPECIFIC PROTEINS RT & POC - OTHER
First on market country
Germany
Authorised representative
Share info GmbH
Last updated
17.07.2026 04:16
Phosphorylated Tau-217 Protein Rapid Test(Serum/Plasma)

Phosphorylated Tau-217 Protein Rapid Test(Serum/Plasma)

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagentSingle use
Manufacturer
SAFECARE BIOTECH (HANGZHOU) CO., LTD.
Manufacturer SRN
CN-MF-000019109
UDI-DI
D-697424646TAU217-002RFWK
Basic UDI-DI
B-697424646TAU217-002RFWK
Reference
Tau217-3011/Tau217-3012
EMDN
W0102160199
EMDN description
SPECIFIC PROTEINS RT & POC - OTHER
First on market country
Germany
Authorised representative
UnicareQ GmbH
Last updated
17.07.2026 04:15
Phosphorylated Tau-217 Protein Rapid Test(Whole blood/Serum/Plasma)

Phosphorylated Tau-217 Protein Rapid Test(Whole blood/Serum/Plasma)

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagentSingle use
Manufacturer
SAFECARE BIOTECH (HANGZHOU) CO., LTD.
Manufacturer SRN
CN-MF-000019109
UDI-DI
D-697424646TAU217-001RDWA
Basic UDI-DI
B-697424646TAU217-001RDWA
Reference
Tau217-4011 Tau217-4012
EMDN
W0102160199
EMDN description
SPECIFIC PROTEINS RT & POC - OTHER
First on market country
Germany
Authorised representative
UnicareQ GmbH
Last updated
17.07.2026 04:15
Phosphorylated Tau-181 Protein Rapid Test(Serum/Plasma)

Phosphorylated Tau-181 Protein Rapid Test(Serum/Plasma)

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagentSingle use
Manufacturer
SAFECARE BIOTECH (HANGZHOU) CO., LTD.
Manufacturer SRN
CN-MF-000019109
UDI-DI
D-697424646TAU181-002RPXF
Basic UDI-DI
B-697424646TAU181-002RPXF
Reference
Tau181-3011/Tau181-3012
EMDN
W0102160199
EMDN description
SPECIFIC PROTEINS RT & POC - OTHER
First on market country
Germany
Authorised representative
UnicareQ GmbH
Last updated
17.07.2026 04:15
Phosphorylated Tau-181 Protein Rapid Test(Whole blood/Serum/Plasma)

Phosphorylated Tau-181 Protein Rapid Test(Whole blood/Serum/Plasma)

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagentSingle use
Manufacturer
SAFECARE BIOTECH (HANGZHOU) CO., LTD.
Manufacturer SRN
CN-MF-000019109
UDI-DI
D-697424646TAU181-001RMX4
Basic UDI-DI
B-697424646TAU181-001RMX4
Reference
Tau181-4011/Tau181-4012
EMDN
W0102160199
EMDN description
SPECIFIC PROTEINS RT & POC - OTHER
First on market country
Germany
Authorised representative
UnicareQ GmbH
Last updated
17.07.2026 04:15
SP10 Protein Rapid Test(Semen)

SP10 Protein Rapid Test(Semen)

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagentSingle use
Manufacturer
SAFECARE BIOTECH (HANGZHOU) CO., LTD.
Manufacturer SRN
CN-MF-000019109
UDI-DI
D-697424646SP10001LA35
Basic UDI-DI
B-697424646SP10001LA35
Reference
SP10-6012
EMDN
W0102160199
EMDN description
SPECIFIC PROTEINS RT & POC - OTHER
First on market country
Germany
Authorised representative
UnicareQ GmbH
Last updated
17.07.2026 04:14
SP10 Protein Rapid Test

SP10 Protein Rapid Test

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagentSingle use
Manufacturer
SAFECARE BIOTECH (HANGZHOU) CO., LTD.
Manufacturer SRN
CN-MF-000019109
UDI-DI
D-697424646SP10000L82G
Basic UDI-DI
B-697424646SP10000L82G
Reference
SP10-6012
EMDN
W0102160199
EMDN description
SPECIFIC PROTEINS RT & POC - OTHER
First on market country
Germany
Authorised representative
Share info GmbH
Last updated
17.07.2026 04:14
Myoglobin Rapid Test (Serum/Plasma)

Myoglobin Rapid Test (Serum/Plasma)

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagentSingle use
Manufacturer
SAFECARE BIOTECH (HANGZHOU) CO., LTD.
Manufacturer SRN
CN-MF-000019109
UDI-DI
D-697424646MYO002RLBC
Basic UDI-DI
B-697424646MYO002RLBC
Reference
MYO-3012
EMDN
W0102160199
EMDN description
SPECIFIC PROTEINS RT & POC - OTHER
First on market country
Germany
Authorised representative
UnicareQ GmbH
Last updated
17.07.2026 04:13
Myoglobin Rapid Test(WB/S/P)

Myoglobin Rapid Test(WB/S/P)

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagentSingle use
Manufacturer
SAFECARE BIOTECH (HANGZHOU) CO., LTD.
Manufacturer SRN
CN-MF-000019109
UDI-DI
D-697424646MYO001RJB3
Basic UDI-DI
B-697424646MYO001RJB3
Reference
MYO-4012
EMDN
W0102160199
EMDN description
SPECIFIC PROTEINS RT & POC - OTHER
First on market country
Germany
Authorised representative
UnicareQ GmbH
Last updated
17.07.2026 04:13
PCT Rapid Test

PCT Rapid Test

IVD generalIVDDNo longer on the marketAnimal tissuesKitNear-patient testingProfessional testingSingle use
Manufacturer
Zhejiang Anji Saianfu Biotechnology Co., Ltd.
Manufacturer SRN
CN-MF-000045029
UDI-DI
69743840304930
Basic UDI-DI
B-69743840304930
Reference
3050801
EMDN
W0102160199
EMDN description
SPECIFIC PROTEINS RT & POC - OTHER
First on market country
-
Authorised representative
Lotus NL B.V.
Last updated
17.07.2026 04:11
Myoglobin FIA Test (Serum/Plasma)

Myoglobin FIA Test (Serum/Plasma)

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagentSingle use
Manufacturer
SAFECARE BIOTECH (HANGZHOU) CO., LTD.
Manufacturer SRN
CN-MF-000019109
UDI-DI
D-697424646MYO001FY3PB
Basic UDI-DI
B-697424646MYO001FY3PB
Reference
MYO-3012F
EMDN
W0102160199
EMDN description
SPECIFIC PROTEINS RT & POC - OTHER
First on market country
Germany
Authorised representative
UnicareQ GmbH
Last updated
17.07.2026 04:10