Identity
- Trade Name
- NIBP cuff EUDAMEDOrantech FDA UDI
- Generic Name
- Blood pressure cuff, single-use FDA UDI
- Device Name
- NIBP cuff EUDAMEDTPU, Single tube, With connector Large Adult Long Range 35.5-59cm FDA UDI
- Model / Reference
- BPD-80TS-W01P EUDAMEDFDA UDI
- Description
- TPU, Single tube, With connector Large Adult Long Range 35.5-59cm FDA UDI
Identifiers
- Primary DI / UDI-DI
- 06941691900511 EUDAMEDFDA UDI
- Basic UDI-DI
- 69416919ORANTECH06QZ EUDAMED
- 510(k) Number
- K173197 FDA UDI
- FDA Product Code
- DXQ FDA UDI
- EMDN Code
- Z1203020285 MULTI-PARAMETER MONITORS - CONSUMABLES EUDAMED
- GMDN Term
- Blood pressure cuff, single-use FDA UDI
Classification
- Device Class
- Class I EUDAMEDClass II FDA UDI
- Regulation Number
- 870.1120 FDA UDI
- Market of Registration
- Denmark EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
Single Use
Yes
Implantable
No
Reusable
Yes
Contains Latex
No
Reprocessed
No
CMR Substance
No
Human-derived
No
Human Tissues
No
Animal Tissues
No
Endocrine Disruptor
No
Administering Medicine
No
Measuring Function
Yes
Incorporates Medicinal Product
No
Prescription Use
No
Over-the-Counter
No
Convenience Kit
No
Combination Product
No
HCT/P
No
Premarket Exempt
No
Lot / Batch Number
Yes
Serial Number
No
Expiration Date
No
Manufacturing Date
Yes
Category: General-purpose multi-parameter bedside monitor
The NIBP cuff is a cutting-edge medical device designed for precise blood pressure monitoring, offering unparalleled accuracy and reliability. Featuring a user-friendly interface and advanced algorithms, this device enables healthcare professionals to make informed decisions and provide high-quality patient care.
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Authorization Coverage (2 countries)
Regulatory Authorizations
CE/MDR
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 69416919ORANTECH06QZ | Class I | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- Orantech Inc.
- EUDAMED SRN
- CN-MF-000013859
- Authorised Representative
- Medten EU ApS DK-AR-000034434
Sources (2)
- EUDAMED 9e076f23-029e-4045-aef4-69bdd54d5f53 61 fields · synced Jul 31, 2026
- FDA UDI 7e8b6f90-eb17-443d-ad97-7fa71bfa3534 34 fields · synced May 30, 2026