Identity
- Trade Name
- ICARE EUDAMED
- Model / Reference
- E875MA EUDAMED3597089 EUDAMED
Identifiers
- Primary DI / UDI-DI
- D-TWMF000022384E875MAFW EUDAMED
- Basic UDI-DI
- B-TWMF000022384E875MAFW EUDAMED
- EMDN Code
- Y0504 ARMS, TORSO AND LEGS RE-EDUCATION DEVICES EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Market of Registration
- Spain EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Implantable
No
EUDAMED
Reusable
No
EUDAMED
Contains Latex
No
EUDAMED
Reprocessed
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
Category: Rubber dam, Hevea-latex
Icare by Sports Art Industrial Co., Ltd. — Class IIa — MDD — listed in EUDAMED — regulatory data on deviCERTS
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Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/MDD
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDD | B-TWMF000022384E875MAFW | Class IIa | Active |
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Manufacturer
- Manufacturer
- Sports Art Industrial Co., Ltd.
- EUDAMED SRN
- TW-MF-000022384
- Authorised Representative
- Emergo Europe B.V. NL-AR-000000116
Sources (1)
- EUDAMED a106fcf5-972b-4f37-a734-6e4a33b0e3c2 61 fields · synced Jul 12, 2026