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Ea-50
EUDAMEDClass A (EU MDR)
Ref LTC130102Ref LTC130101Ref LTC130103Ref LTC130104
Identity
- Trade Name
- EA-50 EUDAMED
- Device Name
- EA-50 EUDAMED
- Model / Reference
- LTC130102 EUDAMEDLTC130101 EUDAMEDLTC130103 EUDAMEDLTC130104 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06972129850290 EUDAMED06972129850283 EUDAMED06972129850566 EUDAMED06972129852263 EUDAMED
- Basic UDI-DI
- 697212985EA50GS EUDAMED
- Direct Marketing DI
- 06972129850290 EUDAMED06972129850283 EUDAMED
- EMDN Code
- W01030708 STAIN SOLUTIONS (HISTOLOGY/CYTOLOGY) EUDAMEDW01030702 CYTOCHEMICAL STAINING REAGENTS EUDAMED
Classification
- Device Class
- Class A EUDAMED
- Market of Registration
- Türkiye 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
Ea-50 by Hunan Lituo Biotechnology 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 | 697212985EA50GS | Class A | Active |
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Manufacturer
- Manufacturer
- Hunan Lituo Biotechnology Co., Ltd.
- EUDAMED SRN
- CN-MF-000029972
- Authorised Representative
- CMC Medical Devices & Drugs SL ES-AR-000000293
Sources (6)
- EUDAMED 9beff90b-b5b4-4cd8-91e9-8326bcc62f2f 61 fields · synced Oct 6, 2026
- EUDAMED 9ca4e849-e5d9-4a32-aa8d-9eb4fda161a5 61 fields · synced May 18, 2026
- EUDAMED 1cd38bb5-9f24-48ee-959a-5f42870e7aaf 61 fields · synced Jul 9, 2026
- EUDAMED 86f7965f-d25e-4e83-96bc-b32f224426ec 61 fields · synced Jul 10, 2026
- EUDAMED 39fff129-d56b-4d2e-98b9-2198d2e01835 61 fields · synced Jul 16, 2026
- EUDAMED 3388fd76-0088-4d1e-b1dc-d2d9217f1ed5 61 fields · synced Jul 17, 2026