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Reusable Abdominal Belt- 60mm Wd, 1.3m Lg
EUDAMEDFDA UDIClass I (EU MDR)
Ref M4602A
Identity
- Trade Name
- REUSABLE ABDOMINAL BELT- 60MM WD,1.3M LG 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. Pre-cut. Water- resistant. 5 belts. Length = 4 1/4 ' (1.3m) Width = 2 3/8" (60mm) FDA UDI
- Model / Reference
- M4602A EUDAMEDREUSABLE ABDOMINAL BELT- 60MM WD,1.3M LG FDA UDI
- Description
- Latex-Free Reusable abdominal belt with button holes. Gray, elastic, washable. Pre-cut. Water- resistant. 5 belts. Length = 4 1/4 ' (1.3m) Width = 2 3/8" (60mm) FDA UDI
Identifiers
- Catalog Number
- M4602A FDA UDI
- Primary DI / UDI-DI
- 20884838003235 EUDAMEDFDA UDI
- Basic UDI-DI
- 0884838BM337SY EUDAMED
- Unit of Use DI
- 00884838003231 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 Abdominal Belt- 60mm Wd, 1.3m Lg 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 |
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Manufacturer
- Manufacturer
- Philips Medical Systems
- EUDAMED SRN
- US-MF-000002321
- Authorised Representative
- Philips Medical Systems Nederland B.V. NL-AR-000001422
Sources (2)
- EUDAMED 6303bad5-a17a-4ded-aaf9-a3525606dd12 61 fields · synced Jun 18, 2026
- FDA UDI 2725a197-647e-4221-bc51-0165cf9875be 37 fields · synced May 30, 2026