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Prostatic Acid Phosphatase (PAP) Detection Kit（Magnetic Solid Phase Chemilumine…
EUDAMEDClass IVD General (EU MDR)
Ref 100 Tests/kit（DR1157-2）Model 100 Tests/kit
Identity
- Trade Name
- Prostatic Acid Phosphatase (PAP) Detection Kit（Magnetic Solid Phase Chemiluminescent Immunoassay） EUDAMED
- Device Name
- Prostatic Acid Phosphatase (PAP) Detection Kit（Magnetic Solid Phase Chemiluminescent Immunoassay） EUDAMED
- Model / Reference
- 100 Tests/kit EUDAMED100 Tests/kit（DR1157-2） EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06974969982957 EUDAMED
- Basic UDI-DI
- B-06974969982957 EUDAMED
- EMDN Code
- W0102030120 PROSTATIC ACID PHOSPHATASE (IC) EUDAMED
Classification
- Device Class
- Class IVD General EUDAMED
- Market of Registration
- Germany EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
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
Prostatic Acid Phosphatase (PAP) Detection Kit（Magnetic Solid Phase Chemilumine… by Biobase Diagnostic Technology (Shandong) Co., Ltd. — Class IVD General…
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-06974969982957 | Class IVD General | Active |
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Manufacturer
- Manufacturer
- Biobase Diagnostic Technology (Shandong) Co., Ltd.
- EUDAMED SRN
- CN-MF-000025964
- Authorised Representative
- Luxus Lebenswelt GmbH DE-AR-000005110
Sources (1)
- EUDAMED cfaa2604-9386-4c84-8dc3-6392e344dc16 61 fields · synced Jun 17, 2026