Identity
- Trade Name
- LASS EUDAMEDFDA UDI
- Generic Name
- Operating table patient positioning set, reusable FDA UDI
- Device Name
- LASS EUDAMEDLASS Small Foam FDA UDI
- Model / Reference
- NA EUDAMEDLP1004 EUDAMEDFDA UDI
- Description
- LASS Small Foam FDA UDI
Identifiers
- Catalog Number
- LP1004 FDA UDI
- Primary DI / UDI-DI
- 00853714008073 EUDAMEDFDA UDI
- Basic UDI-DI
- 0853714008LP100SE EUDAMED
- Direct Marketing DI
- 00853714008073 EUDAMED
- FDA Product Code
- CCX FDA UDI
- EMDN Code
- V0804 PATIENT IMMOBILISERS (in diagnostic or therapeutic procedures) EUDAMED
- GMDN Term
- Operating table patient positioning set, reusable FDA UDI
Classification
- Device Class
- Class I EUDAMEDFDA UDI
- Regulation Number
- 868.6820 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
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Lass by Radux Devices, Inc — 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 | 0853714008LP100SE | Class I | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- Radux Devices, Inc
- EUDAMED SRN
- US-MF-000034745
- Authorised Representative
- MedEnvoy Global BV NL-AR-000024028
Sources (2)
- EUDAMED 181dcd2c-880c-4257-a13f-677568e2729e 61 fields · synced Jul 15, 2026
- FDA UDI 6c570a6f-fc2f-4090-9eb7-c36bbc61a58a 35 fields · synced May 26, 2026