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Grid Landscape Fiber for PaxScan4336W
EUDAMEDFDA UDIClass IIb (EU MDR)
Ref 989601070822
Identity
- Trade Name
- Grid Landscape Fiber for PaxScan4336W EUDAMEDGrid Landscape Fiber PaxScan4336W FDA UDI
- Generic Name
- Stationary x-ray grid FDA UDI
- Device Name
- Grid EUDAMED
- Model / Reference
- 989601070822 EUDAMED9896-010-70822 FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00884838125391 EUDAMEDFDA UDI
- Basic UDI-DI
- 0884838BM450SV EUDAMED
- FDA Product Code
- IXJ FDA UDI
- EMDN Code
- Z11039080 VARIOUS RADIODIAGNOSTIC AND INTERVENTIONAL INSTRUMENTS - HARDWARE ACCESSORIES EUDAMED
- GMDN Term
- Stationary x-ray grid FDA UDI
Classification
- Device Class
- Class IIb EUDAMEDClass I FDA UDI
- Regulation Number
- 892.1910 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
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
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
No
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Grid Landscape Fiber for PaxScan4336W by Philips Medical Systems DMC GmbH — Class IIb — MDR, FDA UDI — listed in EUDAMED, FDA GUDID
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 | 0884838BM450SV | Class IIb | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class IIb | Pending data |
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Manufacturer
- Manufacturer
- Philips Medical Systems DMC GmbH
- EUDAMED SRN
- DE-MF-000005362
Sources (2)
- EUDAMED 935ecc32-bef7-434c-b0cb-7019326d8565 61 fields · synced Jul 31, 2026
- FDA UDI f466a12f-11b3-41b4-ba1a-70721133bbcd 32 fields · synced May 30, 2026