← Back to catalogue
Aspen Elite Pro +, Large
EUDAMEDClass I (EU MDR)
Ref 591504Ref 591404Ref 590404Ref 590504
Identity
- Trade Name
- ASPEN ELITE PRO +, LARGE EUDAMEDASPEN ELITE PRO, LARGE EUDAMED
- Device Name
- LUMBAR EUDAMED
- Model / Reference
- 591504 EUDAMED591404 EUDAMED590404 EUDAMED590504 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 00818249015408 EUDAMED00818249015347 EUDAMED00818249013015 EUDAMED00818249013077 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 +, 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 3340a53c-91cb-48cb-b890-679533250840 61 fields · synced Oct 6, 2026
- EUDAMED 871d2123-053e-4b02-a3bc-7f7334f40607 61 fields · synced May 17, 2026
- EUDAMED 3c922435-0dfd-48bd-a3ac-c363d3996c90 61 fields · synced May 18, 2026
- EUDAMED c6dc014d-4fe7-4c0f-a131-973eeebefb3d 61 fields · synced May 18, 2026