Identity
- Trade Name
- 4a medikal EUDAMED
- Device Name
- Düz Sterilizasyon Rulosu 450 mm x 200 m, 60g 2 İndikatörlü EUDAMED
- Model / Reference
- 4AGR200100/60/2 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08681176422616 EUDAMED
- Basic UDI-DI
- 86811764SW2 EUDAMED
- Direct Marketing DI
- 08681176422616 EUDAMED
- EMDN Code
- S01020102 STERILISATION REELS, GUSSETED, PAPER/PLASTIC FILM EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Romania 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
4a medikal by Dort-A Tip Malz San Ith Ihr Tic Ltd Sti — 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 | 86811764SW2 | Class I | Active |
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Manufacturer
- Manufacturer
- Dort-A Tip Malz San Ith Ihr Tic Ltd Sti
- EUDAMED SRN
- TR-MF-000019642
Sources (2)
- EUDAMED 14a5ca25-ecfb-4533-b61e-bc77e652d238 61 fields · synced Jun 19, 2026
- EUDAMED 833d61c8-24bc-4392-b50a-6bd3320b1572 61 fields · synced Jun 19, 2026