Identity
- Trade Name
- Disposable Pressure Transducer EUDAMEDAntmed FDA UDI
- Generic Name
- Invasive blood pressure transducer set FDA UDI
- Device Name
- Disposable Pressure Transducer EUDAMED
- Model / Reference
- PT181103 EUDAMEDFDA UDI
Identifiers
- Primary DI / UDI-DI
- 06945764400311 EUDAMEDFDA UDI
- Basic UDI-DI
- 69457644DPT0000003EK EUDAMED
- FDA Product Code
- DRS FDA UDI
- EMDN Code
- Z1203020301 INVASIVE BLOOD PRESSURE MONITORING INSTRUMENTS EUDAMED
- GMDN Term
- Invasive blood pressure transducer set FDA UDI
Classification
- Device Class
- Class IIb EUDAMEDClass II FDA UDI
- Regulation Number
- 870.2850 FDA UDI
- Market of Registration
- Germany EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
EUDAMEDFDA UDI
Single Use
Yes
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
Yes
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
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
Yes
FDA UDI
Category: In-line arterial blood sampling set
Disposable Pressure Transducer by ShenZhen Antmed Co., Ltd — Class IIb — 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 | 69457644DPT0000003EK | Class IIb | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class IIb | Pending data |
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Manufacturer
- Manufacturer
- Shenzhen Antmed Co., Ltd
- EUDAMED SRN
- CN-MF-000029659
- Authorised Representative
- MedNet EC-REP C IIb GmbH DE-AR-000011194
Sources (2)
- EUDAMED 39b1d2e4-1311-4f11-9226-d7d8565cc670 61 fields · synced Jun 20, 2026
- FDA UDI 463d47b4-0189-41b1-a220-26af3c579785 33 fields · synced May 30, 2026