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FUTURO™ Premium Compression Ankle Sleeve
EUDAMEDClass I (EU MDR)
Ref 49004SPEAModel 49004DABI
by 3M Company
Identity
- Trade Name
- FUTURO™ Premium Compression Ankle Sleeve EUDAMED
- Device Name
- FUTURO™ Premium Compression Knee Sleeve with Stabilizers EUDAMED
- Model / Reference
- 49004DABI EUDAMED49004SPEA EUDAMED
Identifiers
- Primary DI / UDI-DI
- 04064035196639 EUDAMED
- Basic UDI-DI
- 00511318800100000000003PU EUDAMED
- Direct Marketing DI
- 00068060640574 EUDAMED
- EMDN Code
- Y06120601 PASSIVE ANKLE-FOOT ORTHOSES EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Germany 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
Category: Ankle/foot orthosis
FUTURO™ Premium Compression Ankle Sleeve by 3m Company — Class I — MDR — listed in EUDAMED — regulatory data on deviCERTS
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Also classified as Ankle/foot orthosis.
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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 | 00511318800100000000003PU | Class I | Active |
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Manufacturer
- Manufacturer
- 3M Company
- EUDAMED SRN
- US-MF-000014086
- Authorised Representative
- 3M Deutschland GmbH (Medical) DE-AR-000011642
Sources (1)
- EUDAMED 5a392771-0ac7-43b3-a0e4-c262397ba6a8 61 fields · synced Jun 18, 2026