← Back to catalogue
Auto Stainer
EUDAMEDClass A (EU MDR)
Ref BSZ-CM116-BModel BSJ-DB228Ref BSZ-THI08Ref BSD-GRI08Ref BSZ-CM116
Identity
- Trade Name
- Auto Stainer EUDAMEDAuto-Stainer EUDAMED
- Device Name
- Auto-Stainer EUDAMED
- Model / Reference
- BSJ-DB228 EUDAMEDBSZ-CM116-B EUDAMEDBSZ-THI08 EUDAMEDBSD-GRI08 EUDAMEDBSZ-CM116 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06952383305804 EUDAMED06952383305781 EUDAMED06952383305798 EUDAMED06952383305774 EUDAMED06952383315391 EUDAMED
- Basic UDI-DI
- 695238330006GM EUDAMED
- Direct Marketing DI
- 06952383305804 EUDAMED06952383305781 EUDAMED06952383305798 EUDAMED06952383305774 EUDAMED06952383315391 EUDAMED
- EMDN Code
- W0202059002 AUTOMATED SLIDE STAINERS EUDAMED
Classification
- Device Class
- Class A EUDAMED
- Market of Registration
- Germany EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Microbial Substances
No
EUDAMED
Reagent
No
EUDAMED
Self Testing
No
EUDAMED
Near-Patient Testing
No
EUDAMED
Professional Testing
Yes
EUDAMED
Companion Diagnostics
No
EUDAMED
Surgical Instrument
Yes
EUDAMED
New Device
No
EUDAMED
Category: Microscope slide stainer IVD
Auto Stainer by Baso Diagnostics Inc. Zhuhai — Class A — IVDR — listed in EUDAMED — regulatory data on deviCERTS
Similar devices
Also classified as Microscope slide stainer IVD.
- Hematek® 3000 System — SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD · Class I
- Rack holder, assy. — Leica Biosystems Nussloch GmbH · Class I
- Tinto Detector Complete System — BIO SB, INC. · Class I
- intelliPATH MAX — BIOCARE MEDICAL, LLC · Class I
- BOND — LEICA BIOSYSTEMS MELBOURNE PTY LTD · Class I
- BOND-MAX Processing Module Laboratory - Automated Slide Stainer — LEICA BIOSYSTEMS MELBOURNE PTY LTD · Class A
- HistoPro® — RUSHABH INSTRUMENTS, LLC · Class I
- BOND — LEICA BIOSYSTEMS MELBOURNE PTY LTD · Class I
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 | 695238330006GM | Class A | Active |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Baso Diagnostics Inc. Zhuhai
- EUDAMED SRN
- CN-MF-000050424
- Authorised Representative
- Eunitor GmbH DE-AR-000005081
Sources (9)
- EUDAMED 4c645703-afa8-45ab-ad51-ed083ea972c0 61 fields · synced Jul 29, 2026
- EUDAMED a1c14bcf-72b4-4f26-89c0-9b2dcbec842b 61 fields · synced May 17, 2026
- EUDAMED 92115068-6b17-43b7-8b46-9d8fb7b9e9d7 61 fields · synced May 18, 2026
- EUDAMED 3241f9d7-6eb5-4d28-bdba-091043d8ae3c 61 fields · synced May 18, 2026
- EUDAMED 7f2d7fda-c4ca-46ff-bf51-dc3ee5ced7ee 61 fields · synced May 18, 2026
- EUDAMED bf9c6617-4fa2-458a-96a7-b29751877852 61 fields · synced Jul 10, 2026
- EUDAMED 40ad5e89-6941-49cf-ac56-ffb6b6394389 61 fields · synced Jul 13, 2026
- EUDAMED b4d92177-4c06-4e3d-b2f6-4dc293b16c2d 61 fields · synced Jul 17, 2026
- EUDAMED 050f8322-9adf-4510-b4b8-c788204fd3d0 61 fields · synced Jul 29, 2026