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Sharay Specific IgE (19 Allergens) (CLIA)

EUDAMED

Class IVD General (EU MDR)

Ref 14000385Model Model 15: Bermuda grass G2Ref 14000382Model Model 12: Mountain juniper T6Ref 14000371Model Model 1: Strawberry F44Ref 14000378Model Model 8: Cashew F202Ref 14000379Model Model 9: Pistachio F203Ref 14000374Model Model 4: Peach F95Ref 14000388Model Model 18: Cocklebur W13Ref 14000373Model Model 3: Mango F91Ref 14000377Model Model 7: Almond F20Ref 14000387Model Model 17: Goosefoot W10Ref 14000389Model Model 19: Japanese Hop W22Ref 14000375Model Model 5: Pineapple F210Ref 14000813Ref 14000820Model Model 10: Scallop F338Ref 14000811Ref 14000826Model Model 16: Timothy grass G6Ref 14000827Ref 14000815Ref 14000390Model CRRef 14000828Ref 14000822Ref 14000816Model Model 6: Hazel nut F17

by C-Luminary Biotechnology Co., Ltd.

Identity

Trade Name
Sharay Specific IgE (19 Allergens) (CLIA) EUDAMED
Device Name
Sharay Specific IgE (19 Allergens) (CLIA) EUDAMED
Model / Reference
Model 15: Bermuda grass G2 EUDAMED
14000385 EUDAMED
Model 12: Mountain juniper T6 EUDAMED
14000382 EUDAMED
Model 1: Strawberry F44 EUDAMED
14000371 EUDAMED
Model 8: Cashew F202 EUDAMED
14000378 EUDAMED
Model 9: Pistachio F203 EUDAMED
14000379 EUDAMED
Model 4: Peach F95 EUDAMED
14000374 EUDAMED
Model 18: Cocklebur W13 EUDAMED
14000388 EUDAMED
Model 3: Mango F91 EUDAMED
14000373 EUDAMED
Model 7: Almond F20 EUDAMED
14000377 EUDAMED
Model 17: Goosefoot W10 EUDAMED
14000387 EUDAMED
Model 19: Japanese Hop W22 EUDAMED
14000389 EUDAMED
Model 5: Pineapple F210 EUDAMED
14000375 EUDAMED
14000813 EUDAMED
Model 10: Scallop F338 EUDAMED
14000820 EUDAMED
14000811 EUDAMED
Model 16: Timothy grass G6 EUDAMED
14000826 EUDAMED
14000827 EUDAMED
14000815 EUDAMED
CR EUDAMED
14000390 EUDAMED
14000828 EUDAMED
14000822 EUDAMED
Model 6: Hazel nut F17 EUDAMED
14000816 EUDAMED

Identifiers

Primary DI / UDI-DI
06975070765989 EUDAMED
06975070765958 EUDAMED
06975070765842 EUDAMED
06975070765910 EUDAMED
06975070765927 EUDAMED
06975070765873 EUDAMED
06975070766016 EUDAMED
06975070765866 EUDAMED
06975070765903 EUDAMED
06975070766009 EUDAMED
06975070766023 EUDAMED
06975070765880 EUDAMED
06975070768607 EUDAMED
06975070768676 EUDAMED
06975070768584 EUDAMED
06975070768737 EUDAMED
06975070768744 EUDAMED
06975070768621 EUDAMED
06975070765514 EUDAMED
06975070768751 EUDAMED
06975070768690 EUDAMED
06975070768638 EUDAMED
Basic UDI-DI
B-06975070765989 EUDAMED
B-06975070765958 EUDAMED
B-06975070765842 EUDAMED
B-06975070765910 EUDAMED
B-06975070765927 EUDAMED
B-06975070765873 EUDAMED
B-06975070766016 EUDAMED
B-06975070765866 EUDAMED
B-06975070765903 EUDAMED
B-06975070766009 EUDAMED
B-06975070766023 EUDAMED
B-06975070765880 EUDAMED
B-06975070768607 EUDAMED
B-06975070768676 EUDAMED
B-06975070768584 EUDAMED
B-06975070768737 EUDAMED
B-06975070768744 EUDAMED
B-06975070768621 EUDAMED
B-06975070765514 EUDAMED
B-06975070768751 EUDAMED
B-06975070768690 EUDAMED
B-06975070768638 EUDAMED
EMDN Code
W01020202 IMMUNOGLOBULIN E - SPECIFIC, MONOTEST/MONORESULT 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

EUDAMEDEUDAMED

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

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

Sharay Specific IgE (19 Allergens) (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

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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 (23)

  • EUDAMED 23c859a7-6683-4ad8-ac06-79b6980af69d 61 fields · synced Sep 30, 2026
  • EUDAMED 6b5e5256-3aed-402e-8904-280d066087a3 61 fields · synced May 16, 2026
  • EUDAMED ded98b1b-675f-4c04-9f74-197637d148b5 61 fields · synced May 17, 2026
  • EUDAMED c4838c3f-c7af-48a7-9cd2-db4beb10a9c7 61 fields · synced May 17, 2026
  • EUDAMED 83ff84d1-edee-4b0b-b28b-778b24c3c377 61 fields · synced May 17, 2026
  • EUDAMED ef3b54cc-fed5-41bb-b7e7-da8cfc1ffdda 61 fields · synced May 17, 2026
  • EUDAMED 15ec9941-a67b-4f9b-81fb-e4cfac97a15a 61 fields · synced May 17, 2026
  • EUDAMED 010fe4fc-7e45-41f0-a5ed-5004def01f07 61 fields · synced May 18, 2026
  • EUDAMED f52415da-59a3-4117-aca6-efaf8f4795a3 61 fields · synced May 18, 2026
  • EUDAMED 9fa9f734-73ba-420d-96f5-2a7987607e87 61 fields · synced May 18, 2026
  • EUDAMED b7768bfb-8564-4ffc-968e-c067ba09f715 61 fields · synced May 18, 2026
  • EUDAMED d947438c-2e83-4483-a53f-a75ad673d150 61 fields · synced May 19, 2026
  • EUDAMED 2636f9bf-f607-48ae-ac63-24d1551cdb17 61 fields · synced Jun 18, 2026
  • EUDAMED 3385be0a-ac65-463b-b61a-e1d7f7b75563 61 fields · synced Jul 10, 2026
  • EUDAMED 461d7aa4-a394-49bc-84ed-f6f23c6ffb0d 61 fields · synced Jul 17, 2026
  • EUDAMED fe23805e-7974-4e55-ac56-298f57c8d571 61 fields · synced Jul 18, 2026
  • EUDAMED f2f6cc24-e549-4270-b5f8-cd0eae37d230 61 fields · synced Jul 23, 2026
  • EUDAMED 164c361b-3c75-4765-835f-94310a590dfb 61 fields · synced Jul 27, 2026
  • EUDAMED 10d987c3-3949-4f47-9524-2c2c8084f2ad 61 fields · synced Jul 28, 2026
  • EUDAMED 5132659a-9224-47af-a3f8-b8d4c09b5e26 61 fields · synced Jul 30, 2026
  • EUDAMED 70a5b16a-3568-4064-9453-646ef3010661 61 fields · synced Jul 31, 2026
  • EUDAMED 1d04f60f-b5ec-42d6-becd-973a4118d87e 61 fields · synced Jul 31, 2026
  • EUDAMED a417a923-9ffa-40cd-9e9e-eee975be32b6 61 fields · synced Sep 17, 2026