Identity
- Trade Name
- Henso FDA UDI
- Generic Name
- General specimen microscopy slide IVD, single-use FDA UDI
- Model / Reference
- Microscope Slides FDA UDI
Identifiers
- Primary DI / UDI-DI
- 06970343581648 FDA UDI
- FDA Product Code
- KEW FDA UDI
- GMDN Term
- General specimen microscopy slide IVD, single-use FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 864.3010 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
Yes
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
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Category: General specimen microscopy slide IVD, single-use
Henso by Henso Medical (Hangzhou) Co., Ltd. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as General specimen microscopy slide IVD, single-use.
- KT ™ Premium Slides — Slmp, LLC · Class I
- Non-Adhesion Microscope Slide — New Erie Scientific LLC · Class A
- Non-Adhesion Microscope Slide — New Erie Scientific LLC · Class A
- RANKIN — Yancheng Jingwei Chemicals Co., Ltd · Class I
- OT *!* 75x25x1 rw fbk oMR V=50 Alu Superior — Paul Marienfeld GmbH & Co. KG · Class A
- Non-Adhesion Microscope Slide — New Erie Scientific LLC · Class A
- Fisherbrand — FISHER SCIENTIFIC COMPANY L.L.C. · Class I
- Unimark fbk+Eck orange V=50 Superior — Paul Marienfeld GmbH & Co. KG · Class A
Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Henso Medical (Hangzhou) Co., Ltd.
Sources (1)
- FDA UDI f2ffb297-2f06-4409-b9e5-356b85d3d0bc 32 fields · synced May 30, 2026