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Sharay Specific IgE (Mix of 22 items) (CLIA)

EUDAMED

Class IVD General (EU MDR)

Ref 14000360Model Model 13: Cod F3Ref 14000365Model Model 18: Aspergillus fumigatus M3Ref 14000366Model Model 19: Alternaria alternata M6Ref 14000350Model Model 3: Cat dander E1Ref 14000353Model Model 6: Peanut F13Ref 14000352Model Model 5: Sesame seed F10Ref 14000349Model Model 2: American house dust mite D2Ref 14000356Model Model 9: Crab F23Ref 14000363Model Model 16: House dust H1Ref 14000355Model Model 8: Cow's milk F2Ref 14000369Model Model 22: Mugwort W6Ref 14000367Model Model 20: Willow T12Ref 14000359Model Model 12: Beef F27Ref 14000351Model Model 4: Dog dander E5Ref 14000354Model Model 7: Soybean F14Ref 14000809Model Model 21: Common Ragweed W1Ref 14000795Ref 14000797Ref 14000789Model Model 1: House dust mite D1Ref 14000804Model Model16: House dust H1Ref 14000808Ref 14000796Ref 14000793Ref 14000370Model CRRef 14000810Ref 14000803Model Model 15: Mutton F88Ref 14000799Model Model 11: Egg F245Ref 14000801Ref 14000802Model Model 14: Wheat F4Ref 14000792Ref 14000806Ref 14000800Ref 14000794

by C-Luminary Biotechnology Co., Ltd.

Identity

Trade Name
Sharay Specific IgE (Mix of 22 items) (CLIA) EUDAMED
Device Name
Sharay Specific IgE (Mix of 22 items) (CLIA) EUDAMED
Model / Reference
Model 13: Cod F3 EUDAMED
14000360 EUDAMED
Model 18: Aspergillus fumigatus M3 EUDAMED
14000365 EUDAMED
Model 19: Alternaria alternata M6 EUDAMED
14000366 EUDAMED
Model 3: Cat dander E1 EUDAMED
14000350 EUDAMED
Model 6: Peanut F13 EUDAMED
14000353 EUDAMED
Model 5: Sesame seed F10 EUDAMED
14000352 EUDAMED
Model 2: American house dust mite D2 EUDAMED
14000349 EUDAMED
Model 9: Crab F23 EUDAMED
14000356 EUDAMED
Model 16: House dust H1 EUDAMED
14000363 EUDAMED
Model 8: Cow's milk F2 EUDAMED
14000355 EUDAMED
Model 22: Mugwort W6 EUDAMED
14000369 EUDAMED
Model 20: Willow T12 EUDAMED
14000367 EUDAMED
Model 12: Beef F27 EUDAMED
14000359 EUDAMED
Model 4: Dog dander E5 EUDAMED
14000351 EUDAMED
Model 7: Soybean F14 EUDAMED
14000354 EUDAMED
Model 21: Common Ragweed W1 EUDAMED
14000809 EUDAMED
14000795 EUDAMED
14000797 EUDAMED
Model 1: House dust mite D1 EUDAMED
14000789 EUDAMED
Model16: House dust H1 EUDAMED
14000804 EUDAMED
14000808 EUDAMED
14000796 EUDAMED
14000793 EUDAMED
CR EUDAMED
14000370 EUDAMED
14000810 EUDAMED
Model 15: Mutton F88 EUDAMED
14000803 EUDAMED
Model 11: Egg F245 EUDAMED
14000799 EUDAMED
14000801 EUDAMED
Model 14: Wheat F4 EUDAMED
14000802 EUDAMED
14000792 EUDAMED
14000806 EUDAMED
14000800 EUDAMED
14000794 EUDAMED

Identifiers

Primary DI / UDI-DI
06975070765736 EUDAMED
06975070765781 EUDAMED
06975070765798 EUDAMED
06975070765637 EUDAMED
06975070765668 EUDAMED
06975070765651 EUDAMED
06975070765620 EUDAMED
06975070765699 EUDAMED
06975070765767 EUDAMED
06975070765682 EUDAMED
06975070765828 EUDAMED
06975070765804 EUDAMED
06975070765729 EUDAMED
06975070765644 EUDAMED
06975070765675 EUDAMED
06975070768560 EUDAMED
06975070768423 EUDAMED
06975070768447 EUDAMED
06975070768362 EUDAMED
06975070768515 EUDAMED
06975070768553 EUDAMED
06975070768430 EUDAMED
06975070768409 EUDAMED
06975070765521 EUDAMED
06975070768577 EUDAMED
06975070768508 EUDAMED
06975070768461 EUDAMED
06975070768485 EUDAMED
06975070768492 EUDAMED
06975070768393 EUDAMED
06975070768539 EUDAMED
06975070768478 EUDAMED
06975070768416 EUDAMED
Basic UDI-DI
B-06975070765736 EUDAMED
B-06975070765781 EUDAMED
B-06975070765798 EUDAMED
B-06975070765637 EUDAMED
B-06975070765668 EUDAMED
B-06975070765651 EUDAMED
B-06975070765620 EUDAMED
B-06975070765699 EUDAMED
B-06975070765767 EUDAMED
B-06975070765682 EUDAMED
B-06975070765828 EUDAMED
B-06975070765804 EUDAMED
B-06975070765729 EUDAMED
B-06975070765644 EUDAMED
B-06975070765675 EUDAMED
B-06975070768560 EUDAMED
B-06975070768423 EUDAMED
B-06975070768447 EUDAMED
B-06975070768362 EUDAMED
B-06975070768515 EUDAMED
B-06975070768553 EUDAMED
B-06975070768430 EUDAMED
B-06975070768409 EUDAMED
B-06975070765521 EUDAMED
B-06975070768577 EUDAMED
B-06975070768508 EUDAMED
B-06975070768461 EUDAMED
B-06975070768485 EUDAMED
B-06975070768492 EUDAMED
B-06975070768393 EUDAMED
B-06975070768539 EUDAMED
B-06975070768478 EUDAMED
B-06975070768416 EUDAMED
EMDN Code
W01020202 IMMUNOGLOBULIN E - SPECIFIC, MONOTEST/MONORESULT EUDAMED

Classification

Device Class
Class IVD General EUDAMED
Market of Registration
Germany 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

EUDAMEDEUDAMED

Surgical Instrument

No

EUDAMED

Category: Allergen-specific immunoglobulin E (IgE) antibody IVD, reagent

Sharay Specific IgE (Mix of 22 items) (CLIA) by C-Luminary Biotechnology Co., Ltd. — Class IVD General — IVDD — listed in EUDAMED — regulatory data on deviCERTS

Similar devices

Also classified as Allergen-specific immunoglobulin E (IgE) antibody IVD, reagent.

Authorization Coverage (European Union — 27 member states)

Regulatory Authorizations

European Union Active

CE/IVDD

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

Manufacturer

Manufacturer
C-Luminary Biotechnology Co., Ltd.
EUDAMED SRN
CN-MF-000035089
Authorised Representative
Sungo Cert GmbH DE-AR-000010869

Sources (33)

  • EUDAMED f8d7794d-23ac-47a4-847c-f3ce8bc28898 61 fields · synced Sep 17, 2026
  • EUDAMED d452e24e-455c-4f8b-bf53-0a42edd92625 61 fields · synced May 16, 2026
  • EUDAMED 32faf074-5b26-47b4-aa2a-3b9fee861994 61 fields · synced May 16, 2026
  • EUDAMED 2caae857-9655-4416-90b3-52506d9b16a2 61 fields · synced May 16, 2026
  • EUDAMED 2f006e57-7cad-4023-9e3a-df1f2099a8b5 61 fields · synced May 17, 2026
  • EUDAMED 9812f5b6-8fbf-4104-8a25-4f2f53667068 61 fields · synced May 17, 2026
  • EUDAMED 9ed0ef2e-487e-4dad-8fc5-b802d6e7b6b9 61 fields · synced May 17, 2026
  • EUDAMED 2b1b8710-7406-4700-a4fb-4e416803048a 61 fields · synced May 17, 2026
  • EUDAMED 02cf2ecb-be91-473f-a58a-ee92f028cf44 61 fields · synced May 18, 2026
  • EUDAMED 69bd25fb-b70e-4bfd-a7e0-ee244561fcae 61 fields · synced May 18, 2026
  • EUDAMED 055bb4d7-1c35-46ff-a404-f9c427fab8a1 61 fields · synced May 18, 2026
  • EUDAMED 806af508-3b27-4446-addf-ff9aad35074e 61 fields · synced May 18, 2026
  • EUDAMED 960c07f0-be33-4fcc-823a-9e4ecfa31ea1 61 fields · synced May 18, 2026
  • EUDAMED 19dad5d5-c02c-4f7c-9904-80d24256c41b 61 fields · synced May 19, 2026
  • EUDAMED 764e0e31-ea5d-4a69-b356-6ac12ea853dc 61 fields · synced May 19, 2026
  • EUDAMED 98cfc950-c599-488f-8f88-7f3b198733de 61 fields · synced Jul 9, 2026
  • EUDAMED 9e26cf9f-79f8-4921-9b78-748f27930dba 61 fields · synced Jul 11, 2026
  • EUDAMED 72013a16-a80d-4aff-9f30-a0d220390935 61 fields · synced Jul 11, 2026
  • EUDAMED 4ebb0d67-875e-4765-9916-cc2245149bae 61 fields · synced Jul 11, 2026
  • EUDAMED d489fd3d-b52c-4798-a445-2be37b9f8c87 61 fields · synced Jul 11, 2026
  • EUDAMED c3c278c0-fb14-4212-bbe0-892e5b97b5dc 61 fields · synced Jul 13, 2026
  • EUDAMED 29b846e0-a205-4767-b7ef-7907ddee72eb 61 fields · synced Jul 14, 2026
  • EUDAMED d9ae5c54-06fe-4ab5-ae6c-5f042585608c 61 fields · synced Jul 14, 2026
  • EUDAMED 03c0a4a7-5de5-43a4-970a-76f0d291a12b 61 fields · synced Jul 15, 2026
  • EUDAMED bc4a6e13-56f0-4eb3-8925-2a04f0c38272 61 fields · synced Jul 16, 2026
  • EUDAMED cbdb4b00-7d08-4efa-b312-1857b887ac6c 61 fields · synced Jul 21, 2026
  • EUDAMED 47f5ac86-053c-4f4c-bde7-961c456defcf 61 fields · synced Jul 24, 2026
  • EUDAMED 3d8f1d59-3722-4c7d-9b28-4017f7363eb7 61 fields · synced Jul 25, 2026
  • EUDAMED 27f818ac-4509-4386-a015-f385d7af152c 61 fields · synced Jul 26, 2026
  • EUDAMED 8cc45909-d2f0-482c-a7c8-b4091f188ed3 61 fields · synced Jul 29, 2026
  • EUDAMED 812e8755-0050-4fc4-99c8-17695cca07b5 61 fields · synced Jul 30, 2026
  • EUDAMED e7dfd102-991c-4005-bcf0-4bea3c58d15d 61 fields · synced Aug 3, 2026
  • EUDAMED f25242aa-d088-4800-9310-a4495aa47e51 61 fields · synced Sep 17, 2026