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FUTURO™ Wraparound Ankle Support
EUDAMEDClass I (EU MDR)
Ref 47876NORDModel 47876SPEI
by 3M Company
Identity
- Trade Name
- FUTURO™ Wraparound Ankle Support EUDAMED
- Device Name
- FUTURO™ Wraparound Ankle Support EUDAMED
- Model / Reference
- 47876SPEI EUDAMED47876NORD EUDAMED
Identifiers
- Primary DI / UDI-DI
- 04046719423538 EUDAMED
- Basic UDI-DI
- 06082238401050000000035E9 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
Yes
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™ Wraparound Ankle Support 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 | 06082238401050000000035E9 | 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 38bf24b3-8f5b-40ff-96de-f8abc76ddd57 61 fields · synced Jun 19, 2026