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Immunodiagnostic Products Signal Reagent
EUDAMEDClass A (EU MDR)
Ref 69543760F0003164Model 500mL
Identity
- Trade Name
- Immunodiagnostic Products Signal Reagent EUDAMED
- Device Name
- Immunodiagnostic Products Signal Reagent EUDAMED
- Model / Reference
- 500mL EUDAMED69543760F0003164 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06954376005692 EUDAMED
- Basic UDI-DI
- 69543760F0003164 EUDAMED
- Direct Marketing DI
- 06954376005692 EUDAMED
- EMDN Code
- W0599 IVD GENERAL USE CONSUMABLE DEVICES - OTHER EUDAMED
Classification
- Device Class
- Class A EUDAMED
- Market of Registration
- Germany 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
No
EUDAMED
Companion Diagnostics
No
EUDAMED
Surgical Instrument
No
EUDAMED
New Device
Yes
EUDAMED
Immunodiagnostic Products Signal Reagent by Beijing Leadman Biochemistry 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 | 69543760F0003164 | Class A | Active |
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Manufacturer
- Manufacturer
- Beijing Leadman Biochemistry Co., Ltd.
- EUDAMED SRN
- CN-MF-000020150
- Authorised Representative
- Shanghai International Holding Corp. GmbH(Europe) DE-AR-000000001
Sources (1)
- EUDAMED 2038e328-ae3b-40c5-b11c-3451c87f3c74 61 fields · synced Jun 17, 2026