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Sign in to claim this brandAmazing Biotech (Shanghai) Co., LTD
China·CN-MF-000022383
Last updated May 23, 2026
What Amazing Biotech (Shanghai) Co., LTD makes
Amazing Biotech (Shanghai) Co., Ltd produces single-use swabs under the Flexiswab™ brand, designed for sample collection in clinical and diagnostic settings, as well as an automated processing and detection system called the Amanilab auto P&D System. Their portfolio also includes the ULfast Real Time PCR device, intended for molecular diagnostics and rapid pathogen detection.
The company’s devices are classified under EU regulations as Class A and Class I, with relevant information registered in the EUDAMED database. The manufacturer is based in China and adheres to regulatory requirements applicable to these device categories.
Written from this company's registered devices by an AI model, and not verified by a human reviewer.
Information
- Country
- China
- Address
- 48-52, Gucui Road, Shanghai, China
- Website
- amazingbio.cn
- —
- —
- [email protected]
- Phone
- —
- PRRC Contact
- Zhengping Yang
- EUDAMED SRN
- CN-MF-000022383
- FDA FEI Number
- —
- DUNS Number
- —
Catalogue (6)
| Device | Model / Reference | Registries | Class | Status |
|---|---|---|---|---|
| Flexiswab™ | 0330102 | EUDAMED | Class I | Active |
| Flexiswab™ | 0330104 | EUDAMED | Class I | Active |
| Flexiswab™ | 03301 | EUDAMED | Class I | Active |
| Amanilab auto P&D System | P205410101 | EUDAMED | Class A | Active |
| Flexiswab™ | 0330103 | EUDAMED | Class I | Active |
| ULfast Real Time PCR | SEP5400101 | EUDAMED | Class A | Active |
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