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Sharay Anti-Myositis Antibody Profile IgG (CLIA)

EUDAMED

Class IVD General (EU MDR)

Ref 14000425Model Model 10: Myositis Ro-52Ref 14000424Model Model 9: EJRef 14000421Model Model 6: SRPRef 18177001 Model Model 11: Sharay Anti-Jo-1 IgG,100 Tests/kitRef 14000416Model Model 1: Mi-2Ref 18180001 Model Model 14: Sharay Anti-PL-12 IgG, 100 Tests/kitRef 18182001 Model Model 16: Sharay Anti-Ro-52 IgG, 100 Tests/kitRef 18175001 Model Model 9: Sharay Anti-PM-SCl 100 IgG,100 Tests/kitRef 14000418Model Model 3: PM-Scl 100Ref 14000420Model Model 5: Myositis Jo-1Ref 14000417Model Model 2: KuRef 14000419Model Model 4: PM-Scl 75Ref 18176001Model Model 10: Sharay Anti-PM-SCl 75 IgG,100 Tests/kitRef 14000675Model Model 8: PL-12Ref 14000670Ref 14000672Ref 14000876Model Model 4: Sharay Anti-MDA5 lgG, 50 Tests/kitRef 14000674Model Model 7: PL-7Ref 14000669

by C-Luminary Biotechnology Co., Ltd.

Identity

Trade Name
Sharay Anti-Myositis Antibody Profile IgG (CLIA) EUDAMED
Device Name
Sharay Anti-Myositis Antibody Profile IgG (CLIA) EUDAMED
Model / Reference
Model 10: Myositis Ro-52 EUDAMED
14000425 EUDAMED
Model 9: EJ EUDAMED
14000424 EUDAMED
Model 6: SRP EUDAMED
14000421 EUDAMED
Model 11: Sharay Anti-Jo-1 IgG,100 Tests/kit EUDAMED
18177001 EUDAMED
Model 1: Mi-2 EUDAMED
14000416 EUDAMED
Model 14: Sharay Anti-PL-12 IgG, 100 Tests/kit EUDAMED
18180001 EUDAMED
Model 16: Sharay Anti-Ro-52 IgG, 100 Tests/kit EUDAMED
18182001 EUDAMED
Model 9: Sharay Anti-PM-SCl 100 IgG,100 Tests/kit EUDAMED
18175001 EUDAMED
Model 3: PM-Scl 100 EUDAMED
14000418 EUDAMED
Model 5: Myositis Jo-1 EUDAMED
14000420 EUDAMED
Model 2: Ku EUDAMED
14000417 EUDAMED
Model 4: PM-Scl 75 EUDAMED
14000419 EUDAMED
Model 10: Sharay Anti-PM-SCl 75 IgG,100 Tests/kit EUDAMED
18176001 EUDAMED
Model 8: PL-12 EUDAMED
14000675 EUDAMED
14000670 EUDAMED
14000672 EUDAMED
Model 4: Sharay Anti-MDA5 lgG, 50 Tests/kit EUDAMED
14000876 EUDAMED
Model 7: PL-7 EUDAMED
14000674 EUDAMED
14000669 EUDAMED

Identifiers

Primary DI / UDI-DI
06975070766368 EUDAMED
06975070766351 EUDAMED
06975070766320 EUDAMED
06975070761646 EUDAMED
06975070766276 EUDAMED
06975070761677 EUDAMED
06975070761691 EUDAMED
06975070761622 EUDAMED
06975070766290 EUDAMED
06975070766313 EUDAMED
06975070766283 EUDAMED
06975070766306 EUDAMED
06975070761639 EUDAMED
06975070767884 EUDAMED
06975070767839 EUDAMED
06975070767853 EUDAMED
06975070769284 EUDAMED
06975070767877 EUDAMED
06975070767822 EUDAMED
Basic UDI-DI
B-06975070766368 EUDAMED
B-06975070766351 EUDAMED
B-06975070766320 EUDAMED
B-06975070761646 EUDAMED
B-06975070766276 EUDAMED
B-06975070761677 EUDAMED
B-06975070761691 EUDAMED
B-06975070761622 EUDAMED
B-06975070766290 EUDAMED
B-06975070766313 EUDAMED
B-06975070766283 EUDAMED
B-06975070766306 EUDAMED
B-06975070761639 EUDAMED
B-06975070767884 EUDAMED
B-06975070767839 EUDAMED
B-06975070767853 EUDAMED
B-06975070769284 EUDAMED
B-06975070767877 EUDAMED
B-06975070767822 EUDAMED
EMDN Code
W0102100199 AUTOIMMUNE CONNECTIVE TISSUE DISEASES TESTING - OTHER EUDAMED
W0102100108 JO-1 EUDAMED
W0102109099 AUTO-IMMUNE DISEASE TESTS - OTHER EUDAMED
W0102100109 PM-SCL - ANTIBODIES EUDAMED

Classification

Device Class
Class IVD General EUDAMED
Market of Registration
Germany EUDAMED
Ireland EUDAMED

Clinical & Handling

Sterile

No

EUDAMED

Human Tissues

Yes

EUDAMED

Animal Tissues

Yes

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

Sharay Anti-Myositis Antibody Profile IgG (CLIA) by C-Luminary Biotechnology 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
C-Luminary Biotechnology Co., Ltd.
EUDAMED SRN
CN-MF-000035089
Authorised Representative
Sungo Cert GmbH DE-AR-000010869

Sources (19)

  • EUDAMED 91a6744c-301d-4ed9-9d1b-3ddd328df1ea 61 fields · synced Jul 31, 2026
  • EUDAMED 7e6ae61e-fcdb-431e-be83-6bc5b4ba2e08 61 fields · synced May 16, 2026
  • EUDAMED d59660e0-0565-41e6-8f40-b8ced37ba46d 61 fields · synced May 16, 2026
  • EUDAMED 240c057c-783d-463a-87cd-65f9668b47cc 61 fields · synced May 17, 2026
  • EUDAMED 021a7a06-ea4b-4aea-9ac0-62d0d0951b23 61 fields · synced May 17, 2026
  • EUDAMED c6b08d7f-5a81-440d-ae0f-c5bf34d02222 61 fields · synced May 17, 2026
  • EUDAMED 879e4145-45e8-4451-acc4-e61c1f11fcb7 61 fields · synced May 17, 2026
  • EUDAMED 08d6834e-9e13-4d3e-ac41-6cd63c166172 61 fields · synced May 18, 2026
  • EUDAMED 944d89cf-ca01-4170-bd5c-0e2956b9332f 61 fields · synced May 18, 2026
  • EUDAMED 0ca1fd4f-b1aa-408f-999f-c49ddb14f79c 61 fields · synced May 18, 2026
  • EUDAMED 4e0e1c13-9891-4e71-b0bf-8cbf5f8a043a 61 fields · synced May 18, 2026
  • EUDAMED 42c3e390-1ce0-43b3-9e10-bade49377a0b 61 fields · synced May 19, 2026
  • EUDAMED 5d4d6314-67b6-4cc8-9417-14913a98800d 61 fields · synced May 19, 2026
  • EUDAMED fa82d5f1-8133-4936-a8c0-037c89f92eec 61 fields · synced Jun 14, 2026
  • EUDAMED 18d5681a-c0f7-48c8-bd38-56c4a61cbccd 61 fields · synced Jun 18, 2026
  • EUDAMED 4f57f714-1fba-457f-bef0-2fc1d4a5646a 61 fields · synced Jul 9, 2026
  • EUDAMED ddcc98e6-c270-4bd9-a103-c3dbc804245b 61 fields · synced Jul 14, 2026
  • EUDAMED ffa0e9d3-eef6-4c42-9eb8-0316c2db9b1c 61 fields · synced Jul 15, 2026
  • EUDAMED c99b1c03-72bb-4ab8-b196-0949bf6bdaca 61 fields · synced Jul 25, 2026