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ABPM cuff
FDA UDIEUDAMEDClass II (US FDA UDI)
Ref 04041346101064Model ABPM cuff
by I.E.M. GmbH
Identity
- Trade Name
- Mobil-O-Graph® Manschette, XL EUDAMEDABPM cuff FDA UDI
- Generic Name
- Blood pressure ambulatory recorder FDA UDI
- Device Name
- ABPM Cuff EUDAMED
- Model / Reference
- ABPM cuff EUDAMED04041346101064 EUDAMEDsize XL FDA UDI
Identifiers
- Primary DI / UDI-DI
- 04041346101064 EUDAMEDFDA UDI
- Basic UDI-DI
- 40413461009332 EUDAMED
- Direct Marketing DI
- 04041346101064 EUDAMED
- FDA Product Code
- DXN FDA UDI
- EMDN Code
- Z12040180 GENERAL MEDICINE DIAGNOSIS AND MONITORING INSTRUMENTS - HARDWARE ACCESSORIES EUDAMED
- GMDN Term
- Blood pressure ambulatory recorder FDA UDI
Classification
- Device Class
- Class I EUDAMEDClass II FDA UDI
- Regulation Number
- 870.1130 FDA UDI
- Market of Registration
- Germany 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
Yes
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
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Blood pressure ambulatory recorder
ABPM cuff by I.E.M. GmbH — Class II — MDR, FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS
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Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Unknown
MDR
United States Pending data
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
- Manufacturer
- I.E.M. GmbH
Sources (2)
- FDA UDI 1c5f41c6-617e-4d14-9523-13d0320ab818 32 fields · synced Jun 19, 2026
- EUDAMED 8b7fd602-2095-4db7-95a0-0f378c6ac1a8 61 fields · synced Jun 19, 2026