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Kombi Extra Strong Black, R XL
EUDAMEDClass I (EU MDR)
Ref 7565-35
by Catell AB
Identity
- Trade Name
- Kombi Extra Strong Black, R XL EUDAMED
- Device Name
- Combined EUDAMED
- Model / Reference
- 7565-35 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 07340202101222 EUDAMED
- Basic UDI-DI
- 734020217M8 EUDAMED
- EMDN Code
- Y060613 WRIST-HAND-FINGERS ORTHOSES EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Sweden 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
Kombi Extra Strong Black, R XL by Catell AB — Class I — MDR — listed in EUDAMED — regulatory data on deviCERTS
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 | 734020217M8 | Class I | Active |
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Manufacturer
- Manufacturer
- Catell AB
- EUDAMED SRN
- SE-MF-000000726
Sources (1)
- EUDAMED 07bbf3ad-e695-4559-9d39-d32e1d9be1d1 61 fields · synced Jul 30, 2026