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Lyse
EUDAMEDClass A (EU MDR)
Ref 01.09.31.03.03.02Model H56 LD-IIRef 01.09.31.05.Z5.06Model Z5 LDRef 01.09.31.03.01.06Model LPRef 01.09.31.03.01.04Ref 01.09.31.03.01.03Ref 01.09.31.05.Z5.08
by Zybio Inc.
Identity
- Device Name
- Lyse EUDAMED
- Model / Reference
- H56 LD-II EUDAMED01.09.31.03.03.02 EUDAMEDZ5 LD EUDAMED01.09.31.05.Z5.06 EUDAMEDLP EUDAMED01.09.31.03.01.06 EUDAMED01.09.31.03.01.04 EUDAMED01.09.31.03.01.03 EUDAMED01.09.31.05.Z5.08 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06941967224600 EUDAMED06973262865356 EUDAMED06941967224525 EUDAMED06941967224518 EUDAMED06941967224501 EUDAMED06973262860801 EUDAMED
- Basic UDI-DI
- 697326286000592A EUDAMED69732628600013ZF EUDAMED69732628600060ZQ EUDAMED
- EMDN Code
- W01030199 HAEMATOLOGY REAGENTS - OTHER EUDAMEDW0103010105 CBC-REAGENTS (CLEANING-/DILUTING-/LYSING-/SHEATH-FLUIDS) EUDAMEDW0599 IVD GENERAL USE CONSUMABLE DEVICES - OTHER EUDAMED
Classification
- Device Class
- Class A EUDAMED
- Market of Registration
- Germany EUDAMEDNetherlands 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
New Device
No
EUDAMED
Lyse by Zybio Inc. — 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 | 697326286000592A | Class A | Active |
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Manufacturer
- Manufacturer
- Zybio Inc.
- EUDAMED SRN
- CN-MF-000003349
- Authorised Representative
- Lotus NL B.V. NL-AR-000000121
Sources (6)
- EUDAMED e8c3e1ea-345f-48bd-ba57-635481c9ed02 61 fields · synced Sep 17, 2026
- EUDAMED fedce0a7-e829-4810-ab0c-b0b6f3c863bc 61 fields · synced May 17, 2026
- EUDAMED 1d0f7b39-a90d-4555-81ac-1875f5221222 61 fields · synced May 18, 2026
- EUDAMED 0435c24c-7216-405b-9b7f-0cd47abc1940 61 fields · synced May 18, 2026
- EUDAMED b89d6b8b-5cf1-4455-a781-a06513713cd7 61 fields · synced May 18, 2026
- EUDAMED eb7f4b2f-55b7-4661-96fb-1724fb32de42 61 fields · synced May 19, 2026