Identity
- Trade Name
- 1000ul clear tip EUDAMEDQuaero FDA UDI
- Generic Name
- Pipette tip FDA UDI
- Device Name
- Pipette tip IVD EUDAMED
- Model / Reference
- 1000ul clear tip EUDAMEDC30A0014-B31 1000ul disposable tips with filter(conductive) FDA UDI
Identifiers
- Primary DI / UDI-DI
- 06975379910011 EUDAMEDFDA UDI
- Basic UDI-DI
- 697537991001QG EUDAMED
- FDA Product Code
- JQW FDA UDI
- EMDN Code
- W0503020280 PIPETTES, TIPS - 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
1000ul clear tip 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 | 697537991001QG | 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 636b29fb-7a17-4501-8f25-fd0faa4a5764 61 fields · synced Jun 19, 2026
- FDA UDI 1b282ba4-bc5d-404d-ad53-f1e5891092b5 32 fields · synced May 25, 2026