Identity
- Trade Name
- MOLDCARE RI II EUDAMEDFDA UDI
- Generic Name
- Radiological general body-part positioner FDA UDI
- Device Name
- MOLDCARE RI II EUDAMEDwebsite https://www.alcare.co.jp/en/medical/product/about_moldcare/ FDA UDI
- Model / Reference
- 95941 EUDAMEDHN S FDA UDI
- Description
- website https://www.alcare.co.jp/en/medical/product/about_moldcare/ FDA UDI
Identifiers
- Catalog Number
- 95941 FDA UDI
- Primary DI / UDI-DI
- 04900070959412 EUDAMEDFDA UDI
- Basic UDI-DI
- 49000700000001AK EUDAMED
- FDA Product Code
- KXH FDA UDI
- EMDN Code
- V0804 PATIENT IMMOBILISERS (in diagnostic or therapeutic procedures) EUDAMED
- GMDN Term
- Radiological general body-part positioner FDA UDI
Classification
- Device Class
- Class I EUDAMEDFDA UDI
- Regulation Number
- 892.1830 FDA UDI
- Market of Registration
- Austria EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
EUDAMEDFDA UDI
Single Use
Yes
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
Yes
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
MR Safe FDA UDI
Moldcare Ri Ii by Alcare Co., Ltd. — 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 | 49000700000001AK | Class I | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- ALCARE Co., Ltd.
- EUDAMED SRN
- JP-MF-000006483
- Authorised Representative
- Medical Technology Promedt Consulting GmbH DE-AR-000000085
Sources (2)
- EUDAMED 27b38506-ac10-489d-807a-e85468a96f04 61 fields · synced Aug 1, 2026
- FDA UDI 91be1a0e-c1aa-4d1e-b0ef-3a697f2e1899 37 fields · synced May 30, 2026