Identity
- Trade Name
- PCR tubes EUDAMEDQuaero FDA UDI
- Generic Name
- Pipette tip FDA UDI
- Device Name
- Assay container IVD EUDAMED
- Model / Reference
- Assay container IVD EUDAMEDC30A0014-B32 1000ul disposable tips with filter(conductive) FDA UDI
Identifiers
- Primary DI / UDI-DI
- 06975379910028 EUDAMEDFDA UDI
- Basic UDI-DI
- 697537991002QJ EUDAMED
- FDA Product Code
- JQW FDA UDI
- EMDN Code
- W050301020280 SAMPLES ANALYSES, PLASTIC MICROTUBES - ACCESSORIES EUDAMED
- GMDN Term
- Pipette tip FDA UDI
Classification
- Device Class
- Class A EUDAMEDClass I FDA UDI
- Regulation Number
- 862.2750 FDA UDI
- Market of Registration
- Türkiye EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
EUDAMEDFDA UDI
Single Use
Yes
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
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
No
EUDAMED
Companion Diagnostics
No
EUDAMED
Surgical Instrument
No
EUDAMED
New Device
No
EUDAMED
Prescription Use
No
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
Yes
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
PCR tubes by Zhejiang Biorear Biotechnology Co., Ltd. — Class A — IVDR, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Active
CE/IVDR
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/IVDR | 697537991002QJ | Class A | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class A | Pending data |
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Manufacturer
- Manufacturer
- Zhejiang Biorear Biotechnology Co., Ltd.
- EUDAMED SRN
- CN-MF-000043374
- Authorised Representative
- RIOMAVIX SOCIEDAD LIMITADA ES-AR-000001202
Sources (2)
- EUDAMED 02ffb0c3-e789-442e-a010-f043aea5936c 61 fields · synced Jun 18, 2026
- FDA UDI 6373e9dd-ab4c-4580-9510-85da0a6d0673 32 fields · synced May 30, 2026