Gentle Care Cuff, Large Adult Xl, 1-Tube
EUDAMEDFDA UDIClass I (EU MDR)
Identity
- Trade Name
- GENTLE CARE CUFF, LARGE ADULT XL, 1-TUBE EUDAMEDNIBP Cuffs FDA UDI
- Generic Name
- Blood pressure cuff, reusable FDA UDI
- Device Name
- Easy Care and Gentle Care NIBP Cuffs EUDAMEDEasy Care and Gentle Care Cuffs are not sterile and do not have a defined microbiological condition FDA UDI
- Model / Reference
- Easy Care and Gentle Care NIBP Cuffs EUDAMEDM4578B EUDAMEDGENTLE CARE CUFF, LARGE ADULT XL, 1-TUBE FDA UDI
- Description
- Easy Care and Gentle Care Cuffs are not sterile and do not have a defined microbiological condition FDA UDI
Identifiers
- Catalog Number
- M4578B FDA UDI
- Primary DI / UDI-DI
- 20884838114863 EUDAMEDFDA UDI
- Basic UDI-DI
- 0884838BM1841MX EUDAMED
- Unit of Use DI
- 00884838114869 EUDAMED
- FDA Product Code
- OED FDA UDI
- EMDN Code
- Z1203020285 MULTI-PARAMETER MONITORS - CONSUMABLES EUDAMED
- GMDN Term
- Blood pressure cuff, reusable FDA UDI
Classification
- Device Class
- Class I EUDAMEDClass II FDA UDI
- Regulation Number
- 870.1120 FDA UDI
- Market of Registration
- Austria 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
Yes
Incorporates Medicinal Product
No
Prescription Use
No
Over-the-Counter
No
Convenience Kit
No
Combination Product
No
HCT/P
No
Premarket Exempt
No
Lot / Batch Number
Yes
Serial Number
No
Expiration Date
No
Manufacturing Date
No
Dimensions & Sizes
- Size
- Circumference — 45.000 Centimeter FDA UDI
Category: General-purpose multi-parameter bedside monitor
Gentle Care Cuff, Large Adult Xl, 1-Tube by Philips Medizin Systeme Böblingen GmbH — Class I — MDR, FDA UDI — listed in EUDAMED, FDA GUDID
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Authorization Coverage (2 countries)
Regulatory Authorizations
CE/MDR
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 0884838BM1841MX | Class I | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- Philips Medizin Systeme Böblingen GmbH
- EUDAMED SRN
- DE-MF-000006026
Sources (2)
- EUDAMED f3310809-8a13-4949-821d-d568be32f7a9 61 fields · synced Oct 6, 2026
- FDA UDI f886da95-4fab-46c6-94f6-98bb3c298670 36 fields · synced May 30, 2026