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Hemolytic Agent L
EUDAMEDClass A (EU MDR)
Ref 0320200402Model 2500 mL, 5000 mLRef 0320200401
Identity
- Trade Name
- Hemolytic Agent L EUDAMED
- Device Name
- Hemolytic Agent L EUDAMED
- Model / Reference
- 2500 mL, 5000 mL EUDAMED0320200402 EUDAMED0320200401 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06975984060484 EUDAMED06975984060477 EUDAMED
- Basic UDI-DI
- 69703416803202024HL EUDAMED
- EMDN Code
- W0103010299 OTHER HAEMOGLOBIN (TYPES) TESTING - OTHER EUDAMED
Classification
- Device Class
- Class A EUDAMED
- Market of Registration
- Netherlands 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
Hemolytic Agent L by Shenzhen Lifotronic Technology Co., Ltd. — 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 | 69703416803202024HL | Class A | Active |
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Manufacturer
- Manufacturer
- Shenzhen Lifotronic Technology Co., Ltd.
- EUDAMED SRN
- CN-MF-000005654
- Authorised Representative
- Umedwings Netherlands B.V. NL-AR-000000444
Sources (2)
- EUDAMED 39d87f5c-de76-4263-a62f-3ef6d64a963a 61 fields · synced Aug 5, 2026
- EUDAMED b4a2684c-91bc-4a47-8d45-73f9c8de3d5a 61 fields · synced May 19, 2026