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α-amylase test card (dry chemical method)
EUDAMEDClass IVD General (EU MDR)
Ref 50 pcs/boxModel DiaCard-14
by Jiangsu Konsung Bio-Medical Science And Technology Co., Ltd.
Identity
- Device Name
- α-amylase test card (dry chemical method) EUDAMED
- Model / Reference
- DiaCard-14 EUDAMED50 pcs/box EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06934822535485 EUDAMED
- Basic UDI-DI
- B-06934822535485 EUDAMED
- EMDN Code
- W0101060199 BLOOD TEST STRIPS (CC) - RAPID TESTS AND "POINT OF CARE" - OTHER 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
α-amylase test card (dry chemical method) by Jiangsu Konsung Bio-Medical Science And Technology Co., Ltd. — Class IVD General — IVDD — listed in EUDAMED
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-06934822535485 | Class IVD General | Active |
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Manufacturer
- EUDAMED SRN
- CN-MF-000016839
- Authorised Representative
- Shanghai International Holding Corp. GmbH(Europe) DE-AR-000000001
Sources (1)
- EUDAMED d417c0fe-5e92-4fb2-ad90-d06444af891a 61 fields · synced Jul 8, 2026