Identity
- Trade Name
- Carpus Holder EUDAMEDOP 3D Carpus Holder FDA UDI
- Generic Name
- Limited-view-field CT system FDA UDI
- Device Name
- Patient Positioning Accessory EUDAMEDCarpus holder for Carpus imaging with Orthopantomograph OP 3D FDA UDI
- Model / Reference
- 901074 EUDAMEDFDA UDI
- Description
- Carpus holder for Carpus imaging with Orthopantomograph OP 3D FDA UDI
Identifiers
- Primary DI / UDI-DI
- 06430035874484 EUDAMEDFDA UDI
- Basic UDI-DI
- 643003587PatPosXL EUDAMED
- 510(k) Number
- K180947 FDA UDI
- FDA Product Code
- IWY FDA UDI
- EMDN Code
- Z11030580 RADIOLOGY INSTRUMENTS - HARDWARE ACCESSORIES EUDAMED
- GMDN Term
- Limited-view-field CT system FDA UDI
Classification
- Device Class
- Class I EUDAMEDFDA UDI
- Regulation Number
- 892.1920 FDA UDI
- Market of Registration
- Finland 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
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
No
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Carpus Holder by PaloDEx Group Oy — 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 | 643003587PatPosXL | Class I | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- PaloDEx Group Oy
- EUDAMED SRN
- FI-MF-000004943
Sources (2)
- EUDAMED dac16bcd-9ac7-4fc0-9533-70c52c641d3e 61 fields · synced Jun 17, 2026
- FDA UDI 3c393923-d76d-4650-92d7-a1f3b026c7be 34 fields · synced May 30, 2026