Identity
- Trade Name
- Ralco srl FDA UDI
- Generic Name
- Manual-aperture-control diagnostic x-ray system collimator, motorized FDA UDI
- Model / Reference
- R 302 MLP/A DHHS FDA UDI
Identifiers
- Primary DI / UDI-DI
- 08058776050141 FDA UDI
- FDA Product Code
- KPW FDA UDI
- GMDN Term
- Manual-aperture-control diagnostic x-ray system collimator, motorized FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 892.1610 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
No
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
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
Yes
FDA UDI
Category: Manual-aperture-control diagnostic x-ray system collimator, motorized
Ralco srl by Ralco Srl — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Manual-aperture-control diagnostic x-ray system collimator, motorized.
- Collimare — Collimare, LLC · Class II
- LINEAR MC 150 — CARESTREAM HEALTH, INC. · Class II
- Collimator ML01 II — Siemens Healthcare · Class II
- LINEAR MC 150 — CARESTREAM HEALTH, INC. · Class II
- Collimator AL02 II eL — Siemens Healthcare · Class II
- Ralco srl — RALCO SRL · Class II
- Ralco srl — RALCO SRL · Class II
Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Ralco Srl
Sources (1)
- FDA UDI fc87fc43-9689-4b8d-bdcb-6f5e5a58a829 32 fields · synced May 30, 2026