← Back to catalogue
Hematology Control
EUDAMEDClass IVD General (EU MDR)
Ref 0320900213Model L-5D：High: 3mL/VialRef 0320900207Model L-3D：Low: 2.5mL/VialRef 0320900214Model L-5D：Mix: 3mL/VialRef 0320900209Model L-3D： High: 2.5mL/VialRef 0320900210Model L-3D： Mix: 2.5mL/VialRef 0320900211Model L-5D：Low: 3mL/Vial
Identity
- Trade Name
- Hematology Control EUDAMED
- Device Name
- Hematology Control L-5D EUDAMEDHematology Control L-3D EUDAMED
- Model / Reference
- L-5D：High: 3mL/Vial EUDAMED0320900213 EUDAMEDL-3D：Low: 2.5mL/Vial EUDAMED0320900207 EUDAMEDL-5D：Mix: 3mL/Vial EUDAMED0320900214 EUDAMEDL-3D： High: 2.5mL/Vial EUDAMED0320900209 EUDAMEDL-3D： Mix: 2.5mL/Vial EUDAMED0320900210 EUDAMEDL-5D：Low: 3mL/Vial EUDAMED0320900211 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06976578180632 EUDAMED06976578180076 EUDAMED06976578180618 EUDAMED06976578180656 EUDAMED06976578180601 EUDAMED06976578180069 EUDAMED
- Basic UDI-DI
- B-06976578180632 EUDAMEDB-06976578180076 EUDAMEDB-06976578180618 EUDAMEDB-06976578180656 EUDAMEDB-06976578180601 EUDAMEDB-06976578180069 EUDAMED
- EMDN Code
- W0103010503 MULTILEVEL BLOOD CONTROLS 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
Hematology Control by Wheisman Medical Technology Co., Ltd. — 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-06976578180632 | Class IVD General | Active |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Wheisman Medical Technology Co., Ltd.
- EUDAMED SRN
- CN-MF-000045463
- Authorised Representative
- Shanghai International Holding Corp. GmbH(Europe) DE-AR-000000001
Sources (6)
- EUDAMED 134ca0d6-9ac3-4859-9556-4b81292be848 61 fields · synced Aug 4, 2026
- EUDAMED da33764a-7fd9-42ed-bc76-b27948d9fe8f 61 fields · synced May 16, 2026
- EUDAMED 430cf4cd-2718-4597-8231-fd3930b58fed 61 fields · synced May 17, 2026
- EUDAMED dbe87b8a-93d7-4437-8c38-00ca087a1c1b 61 fields · synced May 17, 2026
- EUDAMED 93f974ec-2447-46d1-9c4a-64877979b406 61 fields · synced May 18, 2026
- EUDAMED d56e2fda-7018-4056-bcae-9ff50ea55f4b 61 fields · synced May 19, 2026