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Fmt
FDA UDIEUDAMEDClass II (US FDA UDI)
Ref IBP-03/007
by Metko Medikal VE Tibbi Cihazlar Dis Ticaret Limited Sirketi
Identity
- Trade Name
- Reusable IBP Cable and Adaptor EUDAMEDFMT FDA UDI
- Generic Name
- Patient monitoring system module, blood pressure, invasive FDA UDI
- Device Name
- Reusable IBP Cable and Adaptor EUDAMEDReusable IBP (Invasive Blood Pressure) Adaptor and Extension Cable FDA UDI
- Model / Reference
- IBP-03/007 EUDAMEDFDA UDI
- Description
- Reusable IBP (Invasive Blood Pressure) Adaptor and Extension Cable FDA UDI
Identifiers
- Primary DI / UDI-DI
- 08698870337634 EUDAMEDFDA UDI
- Basic UDI-DI
- 86988703IBPYYIBPADPXXEW EUDAMED
- FDA Product Code
- IKD FDA UDI
- EMDN Code
- Z1203020301 INVASIVE BLOOD PRESSURE MONITORING INSTRUMENTS EUDAMED
- GMDN Term
- Patient monitoring system module, blood pressure, invasive FDA UDI
Classification
- Device Class
- Class I EUDAMEDClass II FDA UDI
- Regulation Number
- 890.1175 FDA UDI
- Market of Registration
- Türkiye 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
Yes
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
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Fmt by Metko Medikal VE Tibbi Cihazlar Dis Ticaret Limited Sirketi — Class II — FDA UDI — listed in FDA GUDID, EUDAMED — 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
Sources (2)
- FDA UDI 88c0ed8a-7a79-4eb4-91aa-8185ccd640f6 35 fields · synced Oct 7, 2026
- EUDAMED e2fa4209-6ea6-428c-951d-9833675ebce1 61 fields · synced Jun 20, 2026