Identity
- Trade Name
- ASPEN ELITE PRO, MEDIUM EUDAMEDASPEN ELITE PRO +, MEDIUM EUDAMED
- Device Name
- LUMBAR EUDAMED
- Model / Reference
- 590403 EUDAMED591403 EUDAMED591503 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 00818249013008 EUDAMED00818249015330 EUDAMED00818249015392 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
Aspen Elite Pro, Medium 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 |
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Manufacturer
- Manufacturer
- Aspen Medical Products, LLC
- EUDAMED SRN
- US-MF-000001571
- Authorised Representative
- Emergo Europe B.V. NL-AR-000000116
Sources (3)
- EUDAMED 43a4a147-87a2-489d-ad0d-311316940828 61 fields · synced Oct 6, 2026
- EUDAMED 946ae1cc-ee05-44ab-a95a-d45b5bfa6a9e 61 fields · synced May 17, 2026
- EUDAMED 7b215ee9-eed2-4bdf-9cad-e8d5a87e4718 61 fields · synced May 17, 2026