Identity
- Trade Name
- REUSABLE LEG BELT- 32MM X 15M EUDAMEDFetal Measurements FDA UDI
- Generic Name
- Electrode/transducer strap, reusable FDA UDI
- Device Name
- Disposable and reusable fetal belts EUDAMEDLatex-Free Reusable abdominal belt with button holes. Gray, elastic, washable. Roll must be cut to length. Water-resistant. 1 roll. Length = 50' (15m)Width = 1 1/4" (32mm) FDA UDI
- Model / Reference
- M4601A EUDAMEDREUSABLE LEG BELT- 32MM X 15M FDA UDI
- Description
- Latex-Free Reusable abdominal belt with button holes. Gray, elastic, washable. Roll must be cut to length. Water-resistant. 1 roll. Length = 50' (15m)Width = 1 1/4" (32mm) FDA UDI
Identifiers
- Catalog Number
- M4601A FDA UDI
- Primary DI / UDI-DI
- 00884838009424 EUDAMEDFDA UDI
- Basic UDI-DI
- 0884838BM337SY EUDAMED
- FDA Product Code
- HGM FDA UDI
- EMDN Code
- Z12080101 FOETAL MONITORS EUDAMED
- GMDN Term
- Electrode/transducer strap, reusable FDA UDI
Classification
- Device Class
- Class I EUDAMEDClass II FDA UDI
- Regulation Number
- 884.2740 FDA UDI
- Market of Registration
- Austria EUDAMED
- Commercial Distribution
- Not 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
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
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
Prescription Use
No
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
Yes
FDA UDI
Reusable Leg Belt- 32mm X 15m by Philips Medical Systems — 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 | 0884838BM337SY | Class I | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Philips Medical Systems
- EUDAMED SRN
- US-MF-000002321
- Authorised Representative
- Philips Medical Systems Nederland B.V. NL-AR-000001422
Sources (2)
- EUDAMED fc6b3b9e-b3ae-46ac-8240-83c7d4d86a68 61 fields · synced Jun 19, 2026
- FDA UDI e4eea8e5-70b4-4638-9a0e-01e304ee78d5 37 fields · synced May 30, 2026