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NIBP Air Hose
EUDAMEDFDA UDIClass I (EU MDR)
Ref BPA-S-43-10Ref BPC11Ref BPH-AS37-18-43Ref BPA-S-25-11Ref BPC10Ref BPC12Ref BPC48Ref BPA-Y-01M-09M09MRef BPA-Y-01M-32Ref BPA-D-26-1011Ref BPTA-D006-3838-1011Ref BPTA-D-G001W-54-26
Identity
- Trade Name
- NIBP Air Hose EUDAMEDOrantech FDA UDI
- Generic Name
- External cuff/pad connection tubing FDA UDI
- Device Name
- NIBP Air Hose EUDAMEDDraeger Compatible, Adult/Pediatric, Single tube, 3.7m FDA UDI
- Model / Reference
- BPA-S-43-10 EUDAMEDBPC11 EUDAMEDBPH-AS37-18-43 EUDAMEDFDA UDIBPA-S-25-11 EUDAMEDBPC10 EUDAMEDBPC12 EUDAMEDBPC48 EUDAMEDBPA-Y-01M-09M09M EUDAMEDBPA-Y-01M-32 EUDAMEDBPA-D-26-1011 EUDAMEDBPTA-D006-3838-1011 EUDAMEDBPTA-D-G001W-54-26 EUDAMED
- Description
- Draeger Compatible, Adult/Pediatric, Single tube, 3.7m FDA UDI
Identifiers
- Primary DI / UDI-DI
- 06941691974369 EUDAMED06941694775215 EUDAMED06941691957973 EUDAMEDFDA UDI06941691974208 EUDAMED06941694675201 EUDAMED06941691973782 EUDAMED06941691973799 EUDAMED06941691974680 EUDAMED06941691974673 EUDAMED06941691974239 EUDAMED06941691974703 EUDAMED06941691974628 EUDAMED
- 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
EUDAMEDFDA UDI
Single Use
No
FDA UDI
Implantable
No
EUDAMEDFDA UDI
Reusable
No
EUDAMED
Contains Latex
No
EUDAMEDFDA UDI
Reprocessed
No
EUDAMED
CMR Substance
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Endocrine Disruptor
No
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
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
Yes
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Category: General-purpose multi-parameter bedside monitor
NIBP Air Hose by Orantech Inc. — Class I — MDR, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
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Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Active
CE/MDR
United States Pending data
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 (13)
- EUDAMED b71d49bb-a77b-4fd1-bd73-7cc099ad0f97 61 fields · synced Sep 30, 2026
- EUDAMED 68d0c991-4a79-4296-b022-a7d8a1b0d570 61 fields · synced May 16, 2026
- EUDAMED 687789d2-9481-42e3-b71f-076796d13a1f 61 fields · synced May 16, 2026
- EUDAMED 1f22e5f0-b76f-4c01-b160-af4fbec247e9 61 fields · synced May 17, 2026
- EUDAMED 99d25c01-b6a6-497f-a964-eabba571633d 61 fields · synced May 17, 2026
- EUDAMED 807371b9-fd28-4375-a1d8-659d0608f4e0 61 fields · synced May 17, 2026
- EUDAMED 0b09a55f-7bf9-4b4b-83da-0364762ab846 61 fields · synced May 18, 2026
- EUDAMED 3d9b0b06-112f-4b89-849c-3171b9369845 61 fields · synced May 18, 2026
- EUDAMED ce5274bc-8bc6-4b77-b7a4-7391cf38bc11 61 fields · synced May 18, 2026
- EUDAMED 6c304de8-b3fe-4299-a11a-f1298e9bf396 61 fields · synced May 18, 2026
- EUDAMED 097145a0-4acf-47e0-b6a4-a443cb21cc41 61 fields · synced May 19, 2026
- EUDAMED 540f7e8c-9f0a-442f-992d-d5f5e5a84666 61 fields · synced May 19, 2026
- FDA UDI 83de5da3-cd08-4d1f-85b5-c19047084124 33 fields · synced May 30, 2026