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Antigen Retrieval Solution
EUDAMEDClass A (EU MDR)
Ref 4980211Model AlkalinityRef 4980221Model Acidity
Identity
- Trade Name
- Antigen Retrieval Solution EUDAMED
- Device Name
- Antigen Retrieval Solution EUDAMED
- Model / Reference
- Alkalinity EUDAMED4980211 EUDAMEDAcidity EUDAMED4980221 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06977644783467 EUDAMED06977644783450 EUDAMED
- Basic UDI-DI
- 69776447849802199 EUDAMED6977644784980229B EUDAMED
- EMDN Code
- W01029003 BUFFERS (UNASSIGNABLE), SUPPLEM. REAGENTS, ETC (IC) EUDAMED
Classification
- Device Class
- Class A EUDAMED
- Market of Registration
- Spain 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 Solution by Shenzhen Dakewe Bio-Engineering 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 | 69776447849802199 | Class A | Active |
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Manufacturer
- Manufacturer
- Shenzhen Dakewe Bio-engineering Co., Ltd.
- EUDAMED SRN
- CN-MF-000002174
- Authorised Representative
- SUNGO Europe B.V. NL-AR-000000247
Sources (2)
- EUDAMED 392e69e0-bba5-42d5-a9c4-97be8a7b2af8 61 fields · synced Jul 10, 2026
- EUDAMED dfa3a6fd-a789-4a22-a76f-1017cc901baa 61 fields · synced May 19, 2026