Identity
- Trade Name
- E.N.T DRAPE EUDAMED
- Device Name
- STERILE DISPOSABLE SURGICAL GOWNS Small EUDAMED
- Model / Reference
- STANDARD SURGICAL GOWN EUDAMED15-0900-01 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08680829210518 EUDAMED
- Basic UDI-DI
- 0868082921DRPGWNFX EUDAMED
- Direct Marketing DI
- 08680829210518 EUDAMED
- EMDN Code
- T020102 SPECIALISTIC SURGERY DRAPES EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Türkiye EUDAMED
Clinical & Handling
Sterile
Yes
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
E.n.t Drape by Mhk Medi̇kal Teksti̇l San Ve Ti̇c.ltd.şti̇ — 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 | 0868082921DRPGWNFX | Class I | Active |
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Manufacturer
- Manufacturer
- Mhk Medi̇kal Teksti̇l San Ve Ti̇c.ltd.şti̇
- EUDAMED SRN
- TR-MF-000018593
Sources (1)
- EUDAMED 6de9dc9b-8608-44be-8577-b27bd72e311b 61 fields · synced Jun 19, 2026