Identity
- Trade Name
- Antigen Retrieval Buffer EUDAMED
- Device Name
- Antigen Retrieval Buffer EUDAMED
- Model / Reference
- AR3-2.5 EUDAMEDAR3-5000 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06973873141085 EUDAMED06973873141061 EUDAMED
- Basic UDI-DI
- 697387314ARBU3 EUDAMED
- Direct Marketing DI
- 06973873141085 EUDAMED06973873141061 EUDAMED
- EMDN Code
- W01040404 OTHER TISSUE CULTURE ADDITIVES AND SOLUTIONS EUDAMED
Classification
- Device Class
- Class A 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
Antigen Retrieval Buffer by Hangzhou Dalton BioSciences, 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 | 697387314ARBU3 | Class A | Active |
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Manufacturer
- Manufacturer
- Hangzhou Dalton BioSciences, Ltd.
- EUDAMED SRN
- CN-MF-000036196
- Authorised Representative
- Humiss Beratung GmbH DE-AR-000023447
Sources (2)
- EUDAMED cc6e6f06-f8dc-4ca9-be17-2428fd0fd3a1 61 fields · synced Jul 27, 2026
- EUDAMED f65faf83-d0e1-4b0c-a90a-7187cbdaa80a 61 fields · synced May 17, 2026