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Automatic enzyme-linked immunosorbent assay
EUDAMEDClass A (EU MDR)
Ref HB-100EModel HB-1000E, HB-900E, HB-500E, HB-300E, HB-150E, HB-100E
Identity
- Device Name
- Automatic enzyme-linked immunosorbent assay EUDAMED
- Model / Reference
- HB-1000E, HB-900E, HB-500E, HB-300E, HB-150E, HB-100E EUDAMEDHB-100E EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06977221990066 EUDAMED
- Basic UDI-DI
- 697722199IMMUNOSORBENTY2 EUDAMED
- Direct Marketing DI
- 06977221990066 EUDAMED
- EMDN Code
- W0299 IVD INSTRUMENTS - OTHER EUDAMED
Classification
- Device Class
- Class A EUDAMED
- Market of Registration
- Austria EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Microbial Substances
No
EUDAMED
Reagent
No
EUDAMED
Self Testing
No
EUDAMED
Near-Patient Testing
No
EUDAMED
Professional Testing
Yes
EUDAMED
Companion Diagnostics
No
EUDAMED
Surgical Instrument
Yes
EUDAMED
New Device
No
EUDAMED
Automatic enzyme-linked immunosorbent assay by Jiaxing CRED Medical Instrument Co., Ltd. — Class A — IVDR — listed in EUDAMED — regulatory data on deviCERTS
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/IVDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/IVDR | 697722199IMMUNOSORBENTY2 | Class A | Active |
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Manufacturer
- Manufacturer
- Jiaxing CRED Medical Instrument Co., Ltd.
- EUDAMED SRN
- CN-MF-000041285
- Authorised Representative
- SUNGO Europe B.V. NL-AR-000000247
Sources (1)
- EUDAMED b532a9dd-361c-4671-810b-54b9511caaa7 61 fields · synced Aug 2, 2026