Fmt
FDA UDIEUDAMEDClass II (US FDA UDI)
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-01/002 EUDAMEDFDA UDI
- Description
- Reusable IBP (Invasive Blood Pressure) Adaptor and Extension Cable FDA UDI
Identifiers
- Primary DI / UDI-DI
- 08698870336453 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
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
Yes
Over-the-Counter
No
Convenience Kit
No
Combination Product
No
HCT/P
No
Premarket Exempt
Yes
Lot / Batch Number
Yes
Serial Number
Yes
Expiration Date
No
Manufacturing Date
Yes
Category: Patient monitoring system module, blood pressure, invasive
Fmt by Metko Medikal VE Tibbi Cihazlar Dis Ticaret Limited Sirketi — Class II — MDR, FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS
Similar devices
Also classified as Patient monitoring system module, blood pressure, invasive.
- Iradimed — Iradimed Corporation · Class II
- IBP module(FDA/FJ/PK..) — Shenzhen Mindray Bio-Medical Electronics Co. · Class II
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- Surveyor S12/S19 Patient Cable — MORTARA INSTRUMENT, INC. · Class II
- IBP upgrd pkg/no accssry — Shenzhen Mindray Bio-Medical Electronics Co. · Class II
- IBP module(FDA/PK.) — Shenzhen Mindray Bio-Medical Electronics Co. · Class II
- IBP upgrd pkg/with accssry — Shenzhen Mindray Bio-Medical Electronics Co. · Class II
- Iradimed — Iradimed Corporation · Class II
Authorization Coverage (2 countries)
Regulatory Authorizations
MDR
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | MDR | — | Class II | Unknown |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
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Manufacturer
Sources (2)
- FDA UDI 6fa48a20-4534-4206-84c8-efe538090ace 35 fields · synced Oct 7, 2026
- EUDAMED ec20c982-f449-4ffc-9140-7d59b8b7419d 61 fields · synced Oct 7, 2026