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PAP Stain Kit
EUDAMEDClass A (EU MDR)
Ref LTC200103Model 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.Ref LTC200105Model 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/KitRef LTC050105Ref LTC200101Ref LTC060105
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. EUDAMEDLTC200103 EUDAMEDType 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 EUDAMEDLTC200105 EUDAMEDLTC050105 EUDAMEDLTC200101 EUDAMEDLTC060105 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 16972129850198 EUDAMED06972129852454 EUDAMED06972129852393 EUDAMED06972129852430 EUDAMED06972129852423 EUDAMED
- Basic UDI-DI
- 697212985PSKUL EUDAMED
- Direct Marketing DI
- 16972129850198 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
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 (5)
- EUDAMED dc5ef343-5f2f-4bf0-a589-35ab2ca72ee1 61 fields · synced Oct 7, 2026
- EUDAMED 1d51d60a-0708-4304-a902-d210c2ddc6fd 61 fields · synced Jun 18, 2026
- EUDAMED 0358bf20-4398-4cda-b429-647477ac31b6 61 fields · synced Jul 20, 2026
- EUDAMED 76627841-749f-4563-82c0-e5d18f87bbe2 61 fields · synced Jul 30, 2026
- EUDAMED be596e8d-209e-4331-b17a-a9eacdee0dfc 61 fields · synced Aug 1, 2026