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Active filter:Manufacturer SRN:TW-MF-000039217

17 device results listed.

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G322HCATE300MQ

HCA-TE-300

IVD Class AIVDR 2017/746Not intended for EU marketCompanion diagnostics

Manufacturer: ProtectLife International Biomedical Inc.
Manufacturer SRN: TW-MF-000039217
UDI-DI: G322HCATE300MQ
Basic UDI-DI: ++G322HCATE300MQ
Reference: NA
EMDN: W02010399
EMDN description: INTEGRATED / MODULAR CHEMISTRY / IMMUNOCHEMISTRY INSTRUMENTS - OTHER
First on market country: -
Authorised representative: MedNet EC-REP GmbH
Last updated: 15.07.2026 20:36

Manufacturer products Authorised representative products Authorised representative actors View details

G322001236CLE

HCA-TE-300

IVD Class AIVDR 2017/746Not intended for EU marketCompanion diagnosticsReagentSingle use

Manufacturer: ProtectLife International Biomedical Inc.
Manufacturer SRN: TW-MF-000039217
UDI-DI: G322001236CLE
Basic UDI-DI: ++G322001236CLE
Reference: NA
EMDN: W0101060102
EMDN description: CHOLESTEROL TEST STRIPS
First on market country: -
Authorised representative: MedNet EC-REP GmbH
Last updated: 15.07.2026 20:36

Manufacturer products Authorised representative products Authorised representative actors View details

G322001218BL8

HCA-TE-300

IVD Class AIVDR 2017/746Not intended for EU marketReagentSingle use

Manufacturer: ProtectLife International Biomedical Inc.
Manufacturer SRN: TW-MF-000039217
UDI-DI: G322001218BL8
Basic UDI-DI: ++G322001218BL8
Reference: NA
EMDN: W0101060107
EMDN description: HBA1C TEST STRIPS
First on market country: -
Authorised representative: MedNet EC-REP GmbH
Last updated: 15.07.2026 20:36

Manufacturer products Authorised representative products Authorised representative actors View details

ENNOLIFE Clinical Chemistry Analyzer (Non-sterile)

HCA-TE-300

IVD Class AIVDR 2017/746On the marketCompanion diagnosticsDirect markingProfessional testing

Manufacturer: ProtectLife International Biomedical Inc.
Manufacturer SRN: TW-MF-000039217
UDI-DI: ++G322HCATE300
Basic UDI-DI: ++G322G322HCATE300MQQ8
Reference: HCA-TE-300
EMDN: W0201069099
EMDN description: VARIOUS RAPID TEST CHEMISTRY / IMMUNOCHEMISTRY INSTRUMENTS - OTHER
First on market country: Romania
Authorised representative: MedNet EC-REP GmbH
Last updated: 15.07.2026 20:30

Manufacturer products Authorised representative products Authorised representative actors View details

ENNOLIFE Comprehensive II Panel

HCA-TE-300

IVD Class CIVDR 2017/746On the marketCompanion diagnosticsProfessional testingReagentSingle use

Manufacturer: ProtectLife International Biomedical Inc.
Manufacturer SRN: TW-MF-000039217
UDI-DI: ++G3220013H9C
Basic UDI-DI: ++G322G3220013H9C1LUE
Reference: 001-3H9C
EMDN: W0101060109
EMDN description: MULTIPLE PARAMETER BLOOD TEST
First on market country: Romania
Authorised representative: MedNet EC-REP GmbH
Last updated: 15.07.2026 20:30

Manufacturer products Authorised representative products Authorised representative actors View details

ENNOLIFE Comprehensive Plus Panel

HCA-TE-300

IVD Class CIVDR 2017/746On the marketCompanion diagnosticsProfessional testingReagentSingle use

Manufacturer: ProtectLife International Biomedical Inc.
Manufacturer SRN: TW-MF-000039217
UDI-DI: ++G3220013G9A
Basic UDI-DI: ++G322G3220013G9A1ITK
Reference: 001-3G9A
EMDN: W0101060109
EMDN description: MULTIPLE PARAMETER BLOOD TEST
First on market country: Romania
Authorised representative: MedNet EC-REP GmbH
Last updated: 15.07.2026 20:30

Manufacturer products Authorised representative products Authorised representative actors View details

ENNOLIFE Screen Panel

HCA-TE-300

IVD Class CIVDR 2017/746On the marketCompanion diagnosticsProfessional testingReagentSingle use

Manufacturer: ProtectLife International Biomedical Inc.
Manufacturer SRN: TW-MF-000039217
UDI-DI: ++G3220013D2A
Basic UDI-DI: ++G322G3220013D2A18PZ
Reference: 001-3D2A
EMDN: W0101060109
EMDN description: MULTIPLE PARAMETER BLOOD TEST
First on market country: Romania
Authorised representative: MedNet EC-REP GmbH
Last updated: 15.07.2026 20:30

Manufacturer products Authorised representative products Authorised representative actors View details

ENNOLIFE Liver Plus Panel

HCA-TE-300

IVD Class CIVDR 2017/746On the marketCompanion diagnosticsProfessional testingReagentSingle use

Manufacturer: ProtectLife International Biomedical Inc.
Manufacturer SRN: TW-MF-000039217
UDI-DI: ++G3220013B2B
Basic UDI-DI: ++G322G3220013B2B17PE
Reference: 001-3B2B
EMDN: W0101060109
EMDN description: MULTIPLE PARAMETER BLOOD TEST
First on market country: Romania
Authorised representative: MedNet EC-REP GmbH
Last updated: 15.07.2026 20:30

Manufacturer products Authorised representative products Authorised representative actors View details

ENNOLIFE Renal Plus Panel

HCA-TE-300

IVD Class CIVDR 2017/746On the marketCompanion diagnosticsProfessional testingReagentSingle use

Manufacturer: ProtectLife International Biomedical Inc.
Manufacturer SRN: TW-MF-000039217
UDI-DI: ++G322001394A
Basic UDI-DI: ++G322G322001394A16LV
Reference: 001-394A
EMDN: W0101060109
EMDN description: MULTIPLE PARAMETER BLOOD TEST
First on market country: Romania
Authorised representative: MedNet EC-REP GmbH
Last updated: 15.07.2026 20:30

Manufacturer products Authorised representative products Authorised representative actors View details

ENNOLIFE ACR & UPCR Test for Urinalysis (Non-sterile)

HCA-TE-300

IVD Class BIVDR 2017/746On the marketCompanion diagnosticsProfessional testingReagentSingle use

Manufacturer: ProtectLife International Biomedical Inc.
Manufacturer SRN: TW-MF-000039217
UDI-DI: ++G322001256D
Basic UDI-DI: ++G322G322001256D16KZ
Reference: 001-256D
EMDN: W010106020302
EMDN description: URINE SEDIMENT TEST KIT (AUTOMATED)
First on market country: Romania
Authorised representative: MedNet EC-REP GmbH
Last updated: 15.07.2026 20:30

Manufacturer products Authorised representative products Authorised representative actors View details

ENNOLIFE Liver Panel

HCA-TE-300

IVD Class BIVDR 2017/746On the marketCompanion diagnosticsProfessional testingReagentSingle use

Manufacturer: ProtectLife International Biomedical Inc.
Manufacturer SRN: TW-MF-000039217
UDI-DI: ++G322001246F
Basic UDI-DI: ++G322G322001246F17L2
Reference: 001-246F
EMDN: W0101060109
EMDN description: MULTIPLE PARAMETER BLOOD TEST
First on market country: Romania
Authorised representative: MedNet EC-REP GmbH
Last updated: 15.07.2026 20:30

Manufacturer products Authorised representative products Authorised representative actors View details

ENNOLIFE Kidney Panel

HCA-TE-300

IVD Class BIVDR 2017/746On the marketCompanion diagnosticsProfessional testingReagentSingle use

Manufacturer: ProtectLife International Biomedical Inc.
Manufacturer SRN: TW-MF-000039217
UDI-DI: ++G322001246E
Basic UDI-DI: ++G322G322001246E16KT
Reference: 001-246E
EMDN: W0101060109
EMDN description: MULTIPLE PARAMETER BLOOD TEST
First on market country: Romania
Authorised representative: MedNet EC-REP GmbH
Last updated: 15.07.2026 20:30

Manufacturer products Authorised representative products Authorised representative actors View details

ENNOLIFE Kidney Panel II

HCA-TE-300

IVD Class BIVDR 2017/746On the marketCompanion diagnosticsProfessional testingReagentSingle use

Manufacturer: ProtectLife International Biomedical Inc.
Manufacturer SRN: TW-MF-000039217
UDI-DI: ++G322001237A
Basic UDI-DI: ++G322G322001237A12JT
Reference: 001-237A
EMDN: W010106020302
EMDN description: URINE SEDIMENT TEST KIT (AUTOMATED)
First on market country: Romania
Authorised representative: MedNet EC-REP GmbH
Last updated: 15.07.2026 20:30

Manufacturer products Authorised representative products Authorised representative actors View details

ENNOLIFE TC/TG/GLU Panel

HCA-TE-300

IVD Class CIVDR 2017/746On the marketCompanion diagnosticsProfessional testingReagentSingle use

Manufacturer: ProtectLife International Biomedical Inc.
Manufacturer SRN: TW-MF-000039217
UDI-DI: ++G322001236C
Basic UDI-DI: ++G322G322001236CLENG
Reference: 001-236C
EMDN: W01010231
EMDN description: TRIGLYCERIDES
First on market country: Romania
Authorised representative: MedNet EC-REP GmbH
Last updated: 15.07.2026 20:30

Manufacturer products Authorised representative products Authorised representative actors View details

ENNOLIFE Microalbumin(mALB) Test(Non-sterile)

HCA-TE-300

IVD Class BIVDR 2017/746On the marketCompanion diagnosticsProfessional testingReagentSingle use

Manufacturer: ProtectLife International Biomedical Inc.
Manufacturer SRN: TW-MF-000039217
UDI-DI: ++G322001218F
Basic UDI-DI: ++G322G322001218F16KD
Reference: 001-218F
EMDN: W01010201
EMDN description: ALBUMIN (CC)
First on market country: Romania
Authorised representative: MedNet EC-REP GmbH
Last updated: 15.07.2026 20:30

Manufacturer products Authorised representative products Authorised representative actors View details

ENNOLIFE HbA1c Disc

HCA-TE-300

IVD Class CIVDR 2017/746On the marketCompanion diagnosticsProfessional testingReagentSingle use

Manufacturer: ProtectLife International Biomedical Inc.
Manufacturer SRN: TW-MF-000039217
UDI-DI: ++G322001218B
Basic UDI-DI: ++G322G322001218BL8MB
Reference: 001-218B
EMDN: W0103010699
EMDN description: HAEMATOLOGY RAPID TESTS & POINT OF CARE - OTHER
First on market country: Romania
Authorised representative: MedNet EC-REP GmbH
Last updated: 15.07.2026 20:30

Manufacturer products Authorised representative products Authorised representative actors View details

ENNOLIFE HDL Cholesterol Kit (Non-sterile)

HCA-TE-300

IVD Class BIVDR 2017/746On the marketCompanion diagnosticsProfessional testingReagentSingle use

Manufacturer: ProtectLife International Biomedical Inc.
Manufacturer SRN: TW-MF-000039217
UDI-DI: ++G322001218A
Basic UDI-DI: ++G322G322001218A11JA
Reference: 001-218A
EMDN: W01010205
EMDN description: CHOLESTEROL
First on market country: Romania
Authorised representative: MedNet EC-REP GmbH
Last updated: 15.07.2026 20:30

Manufacturer products Authorised representative products Authorised representative actors View details