Identity
- Trade Name
- I-UNICELL Incubator FDA UDI
- Generic Name
- Microplate/tube/assay card incubator IVD FDA UDI
- Model / Reference
- I-UNICELL FDA UDI
Identifiers
- Catalog Number
- I6101 FDA UDI
- Primary DI / UDI-DI
- 06925912711049 FDA UDI
- FDA Product Code
- NSU FDA UDI
- GMDN Term
- Microplate/tube/assay card incubator IVD FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 862.2570 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
No
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
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
No
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Category: Microplate/tube/assay card incubator IVD
I-UNICELL Incubator by Shenzhen YHLO Biotech Co., Ltd. — Class II — IVDR, FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS
Similar devices
Also classified as Microplate/tube/assay card incubator IVD.
- ORTHO — Ortho-Clinical Diagnostics · N
- DG Therm — DIAGNOSTIC GRIFOLS SA · Class II
- BIO-RAD — Bio-Rad · Class I
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Unknown
IVDR
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | IVDR | — | Class II | Unknown |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
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Manufacturer
- Manufacturer
- Shenzhen YHLO Biotech Co., Ltd.
Sources (2)
- FDA UDI ae70d583-ab28-461d-bf89-bcf912e75afd 33 fields · synced Jun 18, 2026
- EUDAMED 1 fields · synced Jun 4, 2026