Identity
- Trade Name
- 4a medical EUDAMED
- Device Name
- Düz Sterilizasyon Rulosu 450 mm x 200 m, 60g 2 İndikatörlü EUDAMED
- Model / Reference
- 4ATR500100 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08681176421183 EUDAMED
- Basic UDI-DI
- 86811764SW2 EUDAMED
- Direct Marketing DI
- 08681176421183 EUDAMED
- EMDN Code
- S01020201 FLAT STERILISATION REELS, TYVEK/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 medical 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 (1)
- EUDAMED 33a72c62-7a57-42d0-b1e3-fb6274c317a8 61 fields · synced Jun 19, 2026