Identity
- Trade Name
- FLX 631 LSO EUDAMED
- Device Name
- LUMBAR EUDAMED
- Model / Reference
- 516313 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 00818249016498 EUDAMED
- Basic UDI-DI
- 081824901LSOH8 EUDAMED
- EMDN Code
- Y060308 LUMBOSACRAL SPINE ORTHOSES EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Netherlands EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Implantable
No
EUDAMED
Reusable
No
EUDAMED
Contains Latex
No
EUDAMED
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
Flx 631 Lso by Aspen Medical Products, LLC — Class I — MDR — listed in EUDAMED — regulatory data on deviCERTS
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/MDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 081824901LSOH8 | Class I | Active |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Aspen Medical Products, LLC
- EUDAMED SRN
- US-MF-000001571
- Authorised Representative
- Emergo Europe B.V. NL-AR-000000116
Sources (1)
- EUDAMED f8ab1970-0cdb-4b0a-8821-2500ccf31195 61 fields · synced Aug 3, 2026