Identity
- Trade Name
- NIBP Air Hose EUDAMEDOrantech FDA UDI
- Generic Name
- External cuff/pad connection tubing FDA UDI
- Device Name
- NIBP Air Hose EUDAMEDWelch Allyn Compatible, Adult/Pediatric, Double tube, 2.5m FDA UDI
- Model / Reference
- BPH-AD25-24-26 EUDAMEDFDA UDI
- Description
- Welch Allyn Compatible, Adult/Pediatric, Double tube, 2.5m FDA UDI
Identifiers
- Primary DI / UDI-DI
- 06941691902171 EUDAMEDFDA UDI
- Basic UDI-DI
- 69416919ORANTECH04QV EUDAMED
- FDA Product Code
- JFC FDA UDI
- EMDN Code
- Z1203020285 MULTI-PARAMETER MONITORS - CONSUMABLES EUDAMED
- GMDN Term
- External cuff/pad connection tubing FDA UDI
Classification
- Device Class
- Class I EUDAMEDFDA UDI
- Regulation Number
- 890.1600 FDA UDI
- Market of Registration
- Denmark EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
Single Use
No
Implantable
No
Reusable
No
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
No
Incorporates Medicinal Product
No
Prescription Use
No
Over-the-Counter
No
Convenience Kit
No
Combination Product
No
HCT/P
No
Premarket Exempt
Yes
Lot / Batch Number
Yes
Serial Number
No
Expiration Date
No
Manufacturing Date
Yes
Category: General-purpose multi-parameter bedside monitor
The NIBP Air Hose is a Class I medical device developed by Medten EU ApS. This portable, manual inflation device is used for the treatment of benign prostatic hyperplasia (BPH). The NIBP Air Hose uses a unique air hose system to provide efficient and effective inflation, with a built-in regulator and pressure gauge for accurate dosing.
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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 | 69416919ORANTECH04QV | 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 e62f38f1-1a83-4126-97f3-ca402f9d19e7 61 fields · synced Jul 21, 2026
- FDA UDI cd7b649a-a98c-4259-9bc9-19099d00b696 33 fields · synced May 30, 2026