Identity
- Device Name
- Tuleja EUDAMED
- Model / Reference
- Sleeve EUDAMED40.4926.000 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 05908447154902 EUDAMED
- Basic UDI-DI
- 59084472NL063MK EUDAMED
- EMDN Code
- L091099 OSTEOSYNTHESIS INSTRUMENTS, REUSABLE - OTHER EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Poland EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Implantable
No
EUDAMED
Reusable
Yes
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: Surgical implant template, reusable
Tuleja by ChM spółka z ograniczoną odpowiedzialnością — Class I — MDR — listed in EUDAMED — regulatory data on deviCERTS
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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 | 59084472NL063MK | Class I | Active |
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Manufacturer
- Manufacturer
- ChM spółka z ograniczoną odpowiedzialnością
- EUDAMED SRN
- PL-MF-000002121
Sources (1)
- EUDAMED 6d4fa5db-852a-41f1-b424-7124a953b28f 61 fields · synced Jun 18, 2026