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Gumotextilná ortéza zápästia a palca ĽAVÁ, ZA-22
EUDAMEDClass I (EU MDR)
Ref J 89225Model Wrist-hand-fingers orthoseModel Wrist-finger orthose
Identity
- Trade Name
- Gumotextilná ortéza zápästia a palca ĽAVÁ, ZA-22 EUDAMED
- Model / Reference
- Wrist-hand-fingers orthose EUDAMEDJ 89225 EUDAMEDWrist-finger orthose EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08585003412286 EUDAMED08585003412293 EUDAMED08585003412309 EUDAMED08585003412316 EUDAMED
- Basic UDI-DI
- 858500J89225ZA22LS98 EUDAMED858500J89225ZA22LM8U EUDAMED858500J89225ZA22LL8S EUDAMED858500J89225ZA22LXLSB EUDAMED
- Direct Marketing DI
- 08585003412286 EUDAMED08585003412293 EUDAMED08585003412309 EUDAMED08585003412316 EUDAMED
- EMDN Code
- Y060613 WRIST-HAND-FINGERS ORTHOSES EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Slovakia 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
Gumotextilná ortéza zápästia a palca ĽAVÁ, ZA-22 by PROTETIKA, a.s. — 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 | 858500J89225ZA22LS98 | Class I | Active |
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Manufacturer
- Manufacturer
- PROTETIKA, a.s.
- EUDAMED SRN
- SK-MF-000004489
Sources (4)
- EUDAMED bdf7ed8e-d274-427d-9bcf-c066e178d6ba 61 fields · synced Oct 6, 2026
- EUDAMED adbf3e3e-dd9e-4e54-99d5-f3aaf2eefa04 61 fields · synced May 17, 2026
- EUDAMED 990405ef-191a-42d5-852a-03434a1db5e6 61 fields · synced May 18, 2026
- EUDAMED e8b436b1-0f39-4aa3-bd4c-c34d9f39f563 61 fields · synced May 19, 2026