Identity
- Trade Name
- Beurer FDA UDI
- Generic Name
- Automatic-inflation electronic sphygmomanometer, portable, arm/wrist FDA UDI
- Device Name
- XL Cuff (33-43 cm) for use with Blood Pressure Monitor Model # BM35 (Type BM35/1) FDA UDI
- Model / Reference
- BM35 XL Cuff (replacement) (Art.- No. 162.934) FDA UDI
- Description
- XL Cuff (33-43 cm) for use with Blood Pressure Monitor Model # BM35 (Type BM35/1) FDA UDI
Identifiers
- Catalog Number
- 162.934 FDA UDI
- Primary DI / UDI-DI
- 00736211161918 FDA UDI
- FDA Product Code
- DXN FDA UDI
- GMDN Term
- Automatic-inflation electronic sphygmomanometer, portable, arm/wrist FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 870.1130 FDA UDI
- Commercial Distribution
- Not 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
No
FDA UDI
Beurer by Beurer North America, L.p. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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
- Beurer North America, L.p.
Sources (1)
- FDA UDI 9796b46e-2182-45ec-94c2-b8cd571489c8 36 fields · synced Jun 1, 2026