Identity
- Trade Name
- kiddieware FDA UDI
- Generic Name
- Medical device pressure monitor FDA UDI
- Model / Reference
- UFR201 FDA UDI
Identifiers
- Primary DI / UDI-DI
- 06953825906184 FDA UDI
- 510(k) Number
- K200802 FDA UDI
- FDA Product Code
- FLL FDA UDI
- GMDN Term
- Medical device pressure monitor FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 880.2910 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
Yes
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Category: Medical device pressure monitor
kiddieware by Shenzhen Urion Technology Co., Ltd. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Medical device pressure monitor.
- Sonohealth — Shenzhen Urion Technology Co., Ltd. · Class II
- AlphagoMed — Shenzhen Urion Technology Co., Ltd. · Class II
- Med One — Shenzhen Urion Technology Co., Ltd. · Class II
- GEKKA — Shenzhen Urion Technology Co., Ltd. · Class II
- MediUSA — Shenzhen Urion Technology Co., Ltd. · Class II
- Telli Health LLC — Shenzhen Urion Technology Co., Ltd. · Class II
- Andesfit Health — Shenzhen Urion Technology Co., Ltd. · Class II
- OXILINE — Shenzhen Urion Technology Co., Ltd. · Class II
Cleared under the same submission
K200802 also covers:
- ALPHAMED — Shenzhen Urion Technology Co., Ltd.
- ALPHAMED — Shenzhen Urion Technology Co., Ltd.
- AlphaMed — Shenzhen Urion Technology Co., Ltd.
- AlphaMed — Shenzhen Urion Technology Co., Ltd.
- AlphaMed — Shenzhen Urion Technology Co., Ltd.
- AlphaMed — Shenzhen Urion Technology Co., Ltd.
- AlphagoMed — Shenzhen Urion Technology Co., Ltd.
- Andesfit Health — Shenzhen Urion Technology Co., Ltd.
- Aoeom — Shenzhen Urion Technology Co., Ltd.
- EZTHINGS — Shenzhen Urion Technology Co., Ltd.
- FGCCJP — Shenzhen Urion Technology Co., Ltd.
- FIGHTECH — Shenzhen Urion Technology Co., Ltd.
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 II | Pending data |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Shenzhen Urion Technology Co., Ltd.
Sources (1)
- FDA UDI 77d5aad4-65f1-45f0-8c67-f9353af21961 33 fields · synced May 30, 2026