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Myeloperoxidase (MPO) Assay Test Kit (Immunoturbidimetric Method)

EUDAMED

Class IVD General (EU MDR)

Ref R1:48mL×2 R2:16mL×2(715)Ref R1:90mL×1 R2:30mL×1(708)Ref R1:60mL×2 R2:20mL×2(706)Ref Calibrator：1mL×5(91068)Ref R1:60mL×1 R2:20mL×1(703)Ref R1:18mL×1 R2:6mL×1(702119)Ref R1:60mL×2 R2:20mL×2(794)Ref R1:40mL×3 R2:20mL×2(704)Ref R1:48mL×2 R2:16mL×2(793)Ref R1:48mL×2 R2:16mL×2(791)Ref R1:18mL×4 R2:6mL×4(707)Ref R1:48mL×2 R2:16mL×2(792)Ref R1:60mL×2 R2:20mL×2(701)

by Biobase Biodustry(Shandong) Co., Ltd.

Identity

Trade Name
Myeloperoxidase (MPO) Assay Test Kit (Immunoturbidimetric Method) EUDAMED
Device Name
Myeloperoxidase (MPO) Assay Test Kit (Immunoturbidimetric Method) EUDAMED
Model / Reference
R1:48mL×2 R2:16mL×2(715) EUDAMED
R1:90mL×1 R2:30mL×1(708) EUDAMED
R1:60mL×2 R2:20mL×2(706) EUDAMED
Calibrator：1mL×5(91068) EUDAMED
R1:60mL×1 R2:20mL×1(703) EUDAMED
R1:18mL×1 R2:6mL×1(702119) EUDAMED
R1:60mL×2 R2:20mL×2(794) EUDAMED
R1:40mL×3 R2:20mL×2(704) EUDAMED
R1:48mL×2 R2:16mL×2(793) EUDAMED
R1:48mL×2 R2:16mL×2(791) EUDAMED
R1:18mL×4 R2:6mL×4(707) EUDAMED
R1:48mL×2 R2:16mL×2(792) EUDAMED
R1:60mL×2 R2:20mL×2(701) EUDAMED

Identifiers

Primary DI / UDI-DI
06936895300526 EUDAMED
06936895300458 EUDAMED
06936895300557 EUDAMED
06936895300632 EUDAMED
06936895300441 EUDAMED
06936895300434 EUDAMED
06936895300564 EUDAMED
06936895300571 EUDAMED
06936895300489 EUDAMED
06936895300465 EUDAMED
06936895300595 EUDAMED
06936895300472 EUDAMED
06936895300540 EUDAMED
Basic UDI-DI
B-06936895300526 EUDAMED
B-06936895300458 EUDAMED
B-06936895300557 EUDAMED
B-06936895300632 EUDAMED
B-06936895300441 EUDAMED
B-06936895300434 EUDAMED
B-06936895300564 EUDAMED
B-06936895300571 EUDAMED
B-06936895300489 EUDAMED
B-06936895300465 EUDAMED
B-06936895300595 EUDAMED
B-06936895300472 EUDAMED
B-06936895300540 EUDAMED
EMDN Code
W01010199 ENZYMES - OTHER EUDAMED

Classification

Device Class
Class IVD General EUDAMED
Market of Registration
Germany EUDAMED

Clinical & Handling

Sterile

No

EUDAMED

Human Tissues

No

EUDAMED

Animal Tissues

No

EUDAMED

Microbial Substances

No

EUDAMED

Reagent

Yes

EUDAMED

Self Testing

No

EUDAMED

Near-Patient Testing

No

EUDAMED

Professional Testing

Yes

EUDAMED

Companion Diagnostics

No

EUDAMED

Surgical Instrument

No

EUDAMED

Myeloperoxidase (MPO) Assay Test Kit (Immunoturbidimetric Method) by Biobase Biodustry(Shandong) Co., Ltd. — Class IVD General — IVDD — listed in EUDAMED

Authorization Coverage (European Union — 27 member states)

Regulatory Authorizations

European Union Active

CE/IVDD

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Manufacturer

Manufacturer
Biobase Biodustry(Shandong) Co., Ltd.
EUDAMED SRN
CN-MF-000025015
Authorised Representative
Luxus Lebenswelt GmbH DE-AR-000005110

Sources (13)

  • EUDAMED 51bd4537-d9a3-442c-86f2-7ad39ec8cd0e 61 fields · synced Oct 6, 2026
  • EUDAMED 95ab28d2-61e0-4d98-b44d-3befea27de98 61 fields · synced May 16, 2026
  • EUDAMED 28931a6a-79fd-4521-b3cc-3cd212d84e8a 61 fields · synced May 16, 2026
  • EUDAMED b163f683-5538-4e58-b36c-a07e4b173c85 61 fields · synced May 17, 2026
  • EUDAMED 082af5f4-ac2a-4a1a-9ba6-6b273e273913 61 fields · synced May 17, 2026
  • EUDAMED 40723692-25ad-49e0-8e20-cf7c1c682c5f 61 fields · synced May 18, 2026
  • EUDAMED 29aac59a-fbdb-41f3-9190-6fb62bb698a8 61 fields · synced May 18, 2026
  • EUDAMED d7408b5d-2309-4962-a245-7daae649ee81 61 fields · synced May 18, 2026
  • EUDAMED 87fef4f2-3f79-436e-b1f6-cba1314560af 61 fields · synced May 18, 2026
  • EUDAMED 606e9b4f-5c47-4225-84cb-d03c12e1390d 61 fields · synced May 19, 2026
  • EUDAMED 312a8831-d2de-4e0a-84b0-292eb0da29b0 61 fields · synced May 19, 2026
  • EUDAMED 289dba30-1bd9-4689-9021-3b9aaf1a5f87 61 fields · synced May 19, 2026
  • EUDAMED 5f41bfbd-6223-491f-8d2d-b9d2340d847c 61 fields · synced May 19, 2026