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Anti-scatter Grid (36 +2 more)
EUDAMEDFDA UDIClass IIb (EU MDR)
Ref 989601061301
Identity
- Trade Name
- Anti-scatter Grid (36/12/100) EUDAMEDX-Ray Grid 36/12/100 FDA UDI
- Generic Name
- Stationary x-ray grid FDA UDI
- Device Name
- Grid EUDAMED
- Model / Reference
- 989601061301 EUDAMED9896-010-61301 FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00884838095106 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
- Netherlands 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
Anti-scatter Grid (36 +2 more) by Philips Medical Systems DMC GmbH — Class IIb — MDR, FDA UDI — listed in EUDAMED, FDA GUDID — 3 models
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 3dd05159-08cc-4703-87c4-7f73c2ef90da 61 fields · synced Aug 4, 2026
- FDA UDI b7d0be3e-855d-405d-9dbc-41698767e8b5 32 fields · synced May 29, 2026