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FUTURO™ Premium Compression Ankle Sleeve
EUDAMEDClass I (EU MDR)
Ref 49005SPEAModel 49004DABIRef 49004NORDRef 49005NORDRef 49005DABI
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 EUDAMED49005SPEA EUDAMED49004NORD EUDAMED49005NORD EUDAMED49005DABI EUDAMED
Identifiers
- Primary DI / UDI-DI
- 04064035196660 EUDAMED04064035196622 EUDAMED04064035196653 EUDAMED04064035196646 EUDAMED
- Basic UDI-DI
- 00511318800100000000003PU EUDAMED
- Direct Marketing DI
- 00068060640581 EUDAMED00068060640574 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 (4)
- EUDAMED fe3fd653-438c-4ecd-8fd2-e6539bdeaf9b 61 fields · synced Aug 1, 2026
- EUDAMED 23f50609-d22f-4f9e-96fc-4444d40c04e7 61 fields · synced May 16, 2026
- EUDAMED e4542c0f-f034-473c-b858-71713dd99093 61 fields · synced May 17, 2026
- EUDAMED d6b8052a-74f2-4925-b7a7-c6421914f31a 61 fields · synced May 18, 2026