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Serological Pipettes
EUDAMEDClass A (EU MDR)
Ref SP01025-2Model SP01001，SP01002，SP01005，SP01010-1，SP01010-2，SP01025-2，SP01050，SP01100，SP02001，SP02002，SP02005，SP02010-1，SP02010-2，SP02025-2，SP02050，SP02100，SP03005，SP03010，SP03025，SP04010, etc
Identity
- Device Name
- Serological Pipettes EUDAMED
- Model / Reference
- SP01001，SP01002，SP01005，SP01010-1，SP01010-2，SP01025-2，SP01050，SP01100，SP02001，SP02002，SP02005，SP02010-1，SP02010-2，SP02025-2，SP02050，SP02100，SP03005，SP03010，SP03025，SP04010, etc EUDAMEDSP01025-2 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06979006047040 EUDAMED
- Basic UDI-DI
- 697900604SP001GS EUDAMED
- EMDN Code
- W0503020199 PIPETTES - OTHER EUDAMED
Classification
- Device Class
- Class A EUDAMED
- Market of Registration
- Austria 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
No
EUDAMED
New Device
No
EUDAMED
Serological Pipettes by Hangzhou Agen 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 | 697900604SP001GS | Class A | Active |
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Manufacturer
- Manufacturer
- Hangzhou Agen Biotechnology Co Ltd
- EUDAMED SRN
- CN-MF-000049623
- Authorised Representative
- SUNGO Europe B.V. NL-AR-000000247
Sources (1)
- EUDAMED 63d33678-0c31-4e13-a437-9fb797534e38 61 fields · synced Jun 18, 2026