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Vrtx Lower Spine Replacement Pads - Standard
EUDAMEDClass I (EU MDR)
Ref 995613
Identity
- Trade Name
- VRTX LOWER SPINE REPLACEMENT PADS - STANDARD EUDAMED
- Device Name
- FLX 456 TLSO EUDAMED
- Model / Reference
- 995613 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 00818249016160 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
Vrtx Lower Spine Replacement Pads - Standard 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 (1)
- EUDAMED 5a6d80a1-9f4f-4d50-b99b-3e0753eeda95 61 fields · synced Jun 19, 2026