← Back to catalogue
Aspen Elite Pro, Xxx-Large
EUDAMEDClass I (EU MDR)
Ref 591407Ref 590407Ref 590507Ref 591507
Identity
- Trade Name
- ASPEN ELITE PRO, XXX-LARGE EUDAMEDASPEN ELITE PRO +, XXX-LARGE EUDAMED
- Device Name
- LUMBAR EUDAMED
- Model / Reference
- 591407 EUDAMED590407 EUDAMED590507 EUDAMED591507 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 00818249015620 EUDAMED00818249015613 EUDAMED00818249015637 EUDAMED00818249015644 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, Xxx-Large 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 (4)
- EUDAMED eec86e1f-e304-4e29-843a-36a3d09abee2 61 fields · synced Oct 6, 2026
- EUDAMED fc32416b-32bc-4ad1-92b9-8fc99556f0eb 61 fields · synced May 18, 2026
- EUDAMED f9310025-10c8-41b1-802d-7bc98fafbb5d 61 fields · synced May 18, 2026
- EUDAMED 52890b45-fd87-48aa-bbd6-3e5c0e264f3f 61 fields · synced May 18, 2026