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Serological Pipettes
EUDAMEDClass A (EU MDR)
Ref SP02001Model 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, etcRef SP01002Ref SP01001 Ref SP01005Ref SP02005Ref SP02050Ref SP02025-2Ref SP01050Ref SP02002Ref SP02100Ref SP02010-2Ref SP01010-1Ref SP03025Ref SP03005
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 EUDAMEDSP02001 EUDAMEDSP01002 EUDAMEDSP01001 EUDAMEDSP01005 EUDAMEDSP02005 EUDAMEDSP02050 EUDAMEDSP02025-2 EUDAMEDSP01050 EUDAMEDSP02002 EUDAMEDSP02100 EUDAMEDSP02010-2 EUDAMEDSP01010-1 EUDAMEDSP03025 EUDAMEDSP03005 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06979006047071 EUDAMED06979006047002 EUDAMED06979006046999 EUDAMED06979006047019 EUDAMED06979006047095 EUDAMED06979006047132 EUDAMED06979006047125 EUDAMED06979006047057 EUDAMED06979006047088 EUDAMED06979006047149 EUDAMED06979006047118 EUDAMED06979006047026 EUDAMED06979006047170 EUDAMED06979006047156 EUDAMED
- Basic UDI-DI
- 697900604SP001GS EUDAMED
- EMDN Code
- W0503020199,W0599 EUDAMEDW0503020199 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 (14)
- EUDAMED d6319c78-f4c2-4738-b55a-211b506b60cc 61 fields · synced Oct 6, 2026
- EUDAMED 53de322a-c48a-4264-b063-fb25d0ea7c6b 61 fields · synced May 16, 2026
- EUDAMED a8083b9d-2c7f-4ca9-8419-074966f1a8a1 61 fields · synced May 16, 2026
- EUDAMED abea4f0d-914b-4cb4-9166-f32f3372217f 61 fields · synced May 17, 2026
- EUDAMED 3e7349e1-3ed3-4792-aa42-7f3fec8a89c9 61 fields · synced May 17, 2026
- EUDAMED c61bcfd8-d395-4e01-ab76-e3460db1f3e0 61 fields · synced May 17, 2026
- EUDAMED 05d5a646-68e4-432f-8d93-e0fb93310936 61 fields · synced May 17, 2026
- EUDAMED a368f0d9-ba3f-4e75-95c8-ec4b70ef2146 61 fields · synced May 18, 2026
- EUDAMED eb794228-8c4f-4c2c-a7f6-991d43fe59ba 61 fields · synced May 18, 2026
- EUDAMED 40a96f7a-2e64-4104-9d2c-013fa7eb99ba 61 fields · synced May 18, 2026
- EUDAMED 7ffb1159-e3c5-4e32-9296-c50d9ad85f62 61 fields · synced May 18, 2026
- EUDAMED 090bf7d0-ee22-4489-a239-d07fa166f5b1 61 fields · synced May 18, 2026
- EUDAMED 8c9d4833-5a55-4edd-91af-d16b368d37bd 61 fields · synced May 18, 2026
- EUDAMED dd5e7112-41fc-4f5b-8ce4-b763cb41e3e6 61 fields · synced May 19, 2026