← Back to catalogue
Aspen Elite Pro +, Xx-Large
EUDAMEDClass I (EU MDR)
Ref 590506Ref 591406Ref 591506
Identity
- Trade Name
- ASPEN ELITE PRO +, XX-LARGE EUDAMEDASPEN ELITE PRO, XX-LARGE EUDAMED
- Device Name
- LUMBAR EUDAMED
- Model / Reference
- 590506 EUDAMED591406 EUDAMED591506 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 00818249013091 EUDAMED00818249015361 EUDAMED00818249015422 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 +, Xx-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 (3)
- EUDAMED e21bfcf8-d99b-488a-8bc1-89096c8d29c3 61 fields · synced Oct 6, 2026
- EUDAMED a0b5b061-1819-4b3b-aaa1-03a909b6b98b 61 fields · synced May 16, 2026
- EUDAMED 82f995d2-e95d-4b6a-b8f1-0d7044c76ff8 61 fields · synced May 17, 2026