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PAP Stain Kit
EUDAMEDClass A (EU MDR)
Ref LTC060101Model Type A specification : 250ml/bottle*3, 500ml/bottle*3, 1L/bottle*3; Type B specification : 250ml/bottle*2, 500ml/bottle*2, 1L/bottle*2; Type C specification :250ml/bottle*2, 500ml/bottle*2, 1L/bottle*2.
Identity
- Trade Name
- PAP Stain Kit EUDAMED
- Device Name
- PAP Stain Kit EUDAMED
- Model / Reference
- Type A specification : 250ml/bottle*3, 500ml/bottle*3, 1L/bottle*3; Type B specification : 250ml/bottle*2, 500ml/bottle*2, 1L/bottle*2; Type C specification :250ml/bottle*2, 500ml/bottle*2, 1L/bottle*2. EUDAMEDLTC060101 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 16972129850150 EUDAMED
- Basic UDI-DI
- 697212985PSKUL EUDAMED
- Direct Marketing DI
- 16972129850150 EUDAMED
- EMDN Code
- W01030708 STAIN SOLUTIONS (HISTOLOGY/CYTOLOGY) 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 d59f4624-2e93-4f09-878b-31ad26f4fcd2 61 fields · synced Jun 18, 2026