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Krebs von den Lungen 6 (KL-6) Test Kit (Homogeneous Chemiluminescence Immunoass…
EUDAMEDClass IVD General (EU MDR)
Ref HCLIA15132
Identity
- Trade Name
- Krebs von den Lungen 6 (KL-6) Test Kit (Homogeneous Chemiluminescence Immunoassay) EUDAMED
- Device Name
- Krebs von den Lungen 6 (KL-6) Test Kit (Homogeneous Chemiluminescence Immunoassay) EUDAMED
- Model / Reference
- HCLIA15132 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06974524061561 EUDAMED
- Basic UDI-DI
- B-06974524061561 EUDAMED
- EMDN Code
- W01030602 SOLUBLE ANTIGENS / RECEPTORS 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
Krebs von den Lungen 6 (KL-6) Test Kit (Homogeneous Chemiluminescence Immunoass… by Nanjing Poclight Biotechnology Co., Ltd. — Class IVD General — IVDD…
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-06974524061561 | Class IVD General | Active |
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Manufacturer
- Manufacturer
- Nanjing Poclight Biotechnology Co., Ltd.
- EUDAMED SRN
- CN-MF-000039609
- Authorised Representative
- HUMISS TRADING S. L. ES-AR-000040177
Sources (2)
- EUDAMED 0fd4a2db-27b6-4592-a4de-2d7b23810ff4 61 fields · synced Oct 7, 2026
- EUDAMED c0148d84-fb44-4c74-9221-bf27b7e694e1 61 fields · synced Oct 7, 2026