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Securmeter Foley Manometer
EUDAMEDFDA UDIClass I (EU MDR)
Ref HM004Model Foley Manometers
Identity
- Trade Name
- Securmeter Foley Manometer EUDAMEDFDA UDI
- Generic Name
- Intra-abdominal pressure measurement set, mechanical FDA UDI
- Device Name
- Inta-abdominal pressure measuring system FDA UDI
- Model / Reference
- Foley Manometers EUDAMEDHM004 EUDAMEDFDA UDI
- Description
- Inta-abdominal pressure measuring system FDA UDI
Identifiers
- Primary DI / UDI-DI
- 08032248471030 EUDAMEDFDA UDI
- Basic UDI-DI
- 8032248471019F EUDAMED
- Direct Marketing DI
- 08032248471030 EUDAMED
- FDA Product Code
- FEN FDA UDI
- EMDN Code
- U050401 INTRA-ABDOMINAL PRESSURE MEASUREMENT CATHETERS, WITHOUT BALLOON EUDAMED
- GMDN Term
- Intra-abdominal pressure measurement set, mechanical FDA UDI
Classification
- Device Class
- Class I EUDAMEDClass II FDA UDI
- Regulation Number
- 876.1620 FDA UDI
- 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
Yes
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
Yes
FDA UDI
Dimensions & Sizes
- Size
- Length — 103 Centimeter FDA UDIOuter Diameter — 6.8 Millimeter FDA UDI
Securmeter Foley Manometer by Delta Med Spa — Class I — MDR, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
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 | 8032248471019F | Class I | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- Delta Med SPA
- EUDAMED SRN
- IT-MF-000027962
Sources (2)
- EUDAMED 3c10876c-a0e1-4493-8ba9-0b060c6e472b 61 fields · synced Jul 10, 2026
- FDA UDI de03cf3b-e50a-4c11-90d6-901b75359d47 34 fields · synced May 30, 2026