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Immunoglobulin G (IgG)
EUDAMEDClass IVD General (EU MDR)
Ref ECH0503306Ref ECH0109306Ref ECH0101306Ref ECH0502306Ref ECH0501306Ref ECH0505306
Identity
- Device Name
- Immunoglobulin G (IgG) EUDAMED
- Model / Reference
- ECH0503306 EUDAMEDECH0109306 EUDAMEDECH0101306 EUDAMEDECH0502306 EUDAMEDECH0501306 EUDAMEDECH0505306 EUDAMED
Identifiers
- Primary DI / UDI-DI
- D-ECH05033066Y EUDAMEDD-ECH01093066N EUDAMEDD-ECH01013064W EUDAMEDD-ECH05023066R EUDAMEDD-ECH05013066J EUDAMEDD-ECH050430677 EUDAMEDD-ECH01053065S EUDAMED
- Basic UDI-DI
- B-ECH05033066Y EUDAMEDB-ECH01093066N EUDAMEDB-ECH01013064W EUDAMEDB-ECH05023066R EUDAMEDB-ECH05013066J EUDAMEDB-ECH050430677 EUDAMEDB-ECH01053065S EUDAMED
- EMDN Code
- W0102010105 IMMUNOGLOBULIN G EUDAMED
Classification
- Device Class
- Class IVD General EUDAMED
- Market of Registration
- Germany EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Human Tissues
No
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
Category: Human immunoglobulin G (IgG) animal conjugate antibody reagent IVD
Immunoglobulin G (IgG) by Maccura Biotechnology Co., Ltd. — Class IVD General — IVDD — listed in EUDAMED — regulatory data on deviCERTS
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Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/IVDD
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/IVDD | B-ECH05033066Y | Class IVD General | Active |
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Manufacturer
- Manufacturer
- Maccura Biotechnology Co., Ltd.
- EUDAMED SRN
- CN-MF-000014618
- Authorised Representative
- Shanghai International Holding Corp. GmbH(Europe) DE-AR-000000001
Sources (7)
- EUDAMED 290a914c-b830-43a8-979d-7f30634e2057 61 fields · synced Oct 6, 2026
- EUDAMED 51801686-f3cd-477b-a4da-1b16d4a08a38 61 fields · synced May 17, 2026
- EUDAMED 57e130ff-d15b-4580-973a-4207b652391b 61 fields · synced May 18, 2026
- EUDAMED 9ed6877b-e255-401d-b4e2-ee0148a27a76 61 fields · synced May 18, 2026
- EUDAMED 9b9007f8-e587-4dcb-bcfa-6e2e52f54d9a 61 fields · synced May 18, 2026
- EUDAMED 5cdfad1d-5a78-489e-92ed-26772de03b4a 61 fields · synced May 19, 2026
- EUDAMED 42428224-d57c-4084-afa2-e4c7c6523f4d 61 fields · synced May 19, 2026