Identity
- Trade Name
- ELITE TLSO, MEDIUM EUDAMEDELITE TLSO, MEDIUM EUDAMED
- Device Name
- FLX 456 TLSO EUDAMED
- Model / Reference
- 591603 EUDAMED590603 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 00818249015514 EUDAMED00818249015453 EUDAMED
- Basic UDI-DI
- 081824901TLSOEF EUDAMED
- EMDN Code
- Y060306 THORACOLUMBAR 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
Elite Tlso, 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 | 081824901TLSOEF | 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 (2)
- EUDAMED 7962de95-58b8-4897-8184-f960e87a6197 61 fields · synced Jun 20, 2026
- EUDAMED 1566247b-030e-4836-803f-4db4b9e79d10 61 fields · synced May 17, 2026