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Enema Set
EUDAMEDClass I (EU MDR)
Ref ZLN
by ZARYS International Spółka z ograniczoną odpowiedzialnością
Identity
- Trade Name
- ENEMA SET EUDAMED
- Device Name
- non-sterile enema bags EUDAMED
- Model / Reference
- ZLN EUDAMED
Identifiers
- Primary DI / UDI-DI
- 05907996872725 EUDAMED
- Basic UDI-DI
- 59079968G02060399EV EUDAMED
- EMDN Code
- G02060399 DEVICES FOR COLORECTAL DIAGNOSTIC PROCEDURES - OTHER EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Poland EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Implantable
No
EUDAMED
Reusable
No
EUDAMED
Contains Latex
No
EUDAMED
Reprocessed
No
EUDAMED
CMR Substance
Yes
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
Enema Set by ZARYS International Spółka z ograniczoną odpowiedzialnością — 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 | 59079968G02060399EV | Class I | Active |
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Manufacturer
- EUDAMED SRN
- PL-MF-000000410
Sources (1)
- EUDAMED b884ad41-da32-4ffd-b011-5c787cf6afe6 61 fields · synced Oct 6, 2026