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Aspen Elite Active, X-Small
EUDAMEDClass I (EU MDR)
Ref 590201Ref 591201Ref 591301Ref 590301
Identity
- Trade Name
- ASPEN ELITE ACTIVE, X-SMALL EUDAMEDASPEN ELITE ACTIVE +, X-SMALL EUDAMED
- Device Name
- LUMBAR EUDAMED
- Model / Reference
- 590201 EUDAMED591201 EUDAMED591301 EUDAMED590301 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 00818249012803 EUDAMED00818249013596 EUDAMED00818249013534 EUDAMED00818249012926 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 Active, X-Small 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 (4)
- EUDAMED 831fb042-66ba-42ff-b4a4-bc83c7485e44 61 fields · synced Oct 6, 2026
- EUDAMED dfe88044-0889-4f59-9215-1e362a931c7c 61 fields · synced May 17, 2026
- EUDAMED 89614da2-de17-4bd7-acc0-bb967f61a815 61 fields · synced May 17, 2026
- EUDAMED 271ffb11-cad5-4140-907a-cdcbe01d80fd 61 fields · synced May 18, 2026