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Homocysteine (HCY) Kit (Enzymatic Method)
EUDAMEDClass IVD General (EU MDR)
Ref 01.09.05.05.EC.02
by Zybio Inc.
Identity
- Device Name
- Homocysteine (HCY) Kit (Enzymatic Method) EUDAMED
- Model / Reference
- 01.09.05.05.EC.02 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06941967223399 EUDAMED
- Basic UDI-DI
- B-06941967223399 EUDAMED
- EMDN Code
- W01021307 HOMOCYSTEINE EUDAMED
Classification
- Device Class
- Class IVD General EUDAMED
- Market of Registration
- Germany EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
Yes
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
Homocysteine (HCY) Kit (Enzymatic Method) by Zybio Inc. — Class IVD General — IVDD — listed in EUDAMED — regulatory data on deviCERTS
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-06941967223399 | Class IVD General | Active |
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Manufacturer
- Manufacturer
- Zybio Inc.
- EUDAMED SRN
- CN-MF-000003349
- Authorised Representative
- Lotus NL B.V. NL-AR-000000121
Sources (1)
- EUDAMED 2e1f024a-3eb4-460c-a0a0-d5befe087fc5 61 fields · synced Aug 1, 2026