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Pap Stain Kit
EUDAMEDClass A (EU MDR)
Ref LTC060101Model Type A: 250ml*3/Kit, 500ml*3/Kit, 1L*3/Kit; Type B: 250ml*2/Kit, 500m1*2/Kit, 1L*2/Kit; Type C: 250ml*2/Kit, 500m1*2/Kit, 1L*2/Kit
Identity
- Trade Name
- Pap Stain Kit EUDAMED
- Device Name
- PAP Stain Kit EUDAMED
- Model / Reference
- Type A: 250ml*3/Kit, 500ml*3/Kit, 1L*3/Kit; Type B: 250ml*2/Kit, 500m1*2/Kit, 1L*2/Kit; Type C: 250ml*2/Kit, 500m1*2/Kit, 1L*2/Kit EUDAMEDLTC060101 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06972129852409 EUDAMED
- Basic UDI-DI
- 697212985PSKUL EUDAMED
- EMDN Code
- W01030702 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
Pap Stain Kit 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 | 697212985PSKUL | 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 (1)
- EUDAMED 674c7e6b-3e56-42d3-b34b-208aa533d5af 61 fields · synced Jun 19, 2026