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Hælsporeindlæg Medium
EUDAMEDClass I (EU MDR)
Ref 845442Model IndlægssålerModel Hælsporeindlæg Medium
Identity
- Trade Name
- Hælsporeindlæg Medium EUDAMED
- Device Name
- Hælsporeindlæg Medium EUDAMED
- Model / Reference
- Indlægssåler EUDAMED845442 EUDAMEDHælsporeindlæg Medium EUDAMED
Identifiers
- Primary DI / UDI-DI
- 05719808454421 EUDAMED
- Basic UDI-DI
- 5719808insoleB5 EUDAMEDB-05719808454421 EUDAMED
- EMDN Code
- Y061203 ORTHOSES, FOOT (INCLUDING INSOLES AND INSERTS) EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Denmark 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: Orthotic insole, prefabricated, non-antimicrobial
Hælsporeindlæg Medium by tacco international nv — Class I — MDD, MDR — listed in EUDAMED — regulatory data on deviCERTS
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Also classified as Orthotic insole, prefabricated, non-antimicrobial.
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Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/MDD
European Union Active
CE/MDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDD | 5719808insoleB5 | Class I | Active |
| EUDAMED | European Union | CE/MDR | 5719808insoleB5 | Class I | Active |
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Manufacturer
- Manufacturer
- tacco international nv
- EUDAMED SRN
- BE-MF-000042561
Sources (2)
- EUDAMED f3a3b404-c152-4b8b-bbe8-de3532ad09e8 61 fields · synced Oct 6, 2026
- EUDAMED ccdb742a-72f2-4fb9-917f-56f55a3b8e1d 61 fields · synced May 17, 2026