Identity
- Trade Name
- Electronlc Blood Pressure Monltor FDA UDI
- Generic Name
- Noninvasive blood pressure physical simulator FDA UDI
- Model / Reference
- KWL-W01 FDA UDI
Identifiers
- Primary DI / UDI-DI
- 06971344890616 FDA UDI
- 510(k) Number
- K212171 FDA UDI
- FDA Product Code
- DXN FDA UDI
- GMDN Term
- Noninvasive blood pressure physical simulator FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 870.1130 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
Yes
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
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
Yes
FDA UDI
Category: Noninvasive blood pressure physical simulator
Electronlc Blood Pressure Monltor by Dongguan Kangweile Electronic Technology Co., Ltd. — Class II — FDA UDI — listed in FDA GUDID
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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 |
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Manufacturer
- Manufacturer
- Dongguan Kangweile Electronic Technology Co., Ltd.
Sources (1)
- FDA UDI e2513360-3d54-45a1-b444-0d58b1368b24 33 fields · synced May 30, 2026