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U Split Drape
EUDAMEDClass I (EU MDR)
Ref 15-153-02Model STANDARD SURGICAL GOWN
Identity
- Trade Name
- U SPLIT DRAPE EUDAMED
- Device Name
- STERILE DISPOSABLE SURGICAL GOWNS Small EUDAMED
- Model / Reference
- STANDARD SURGICAL GOWN EUDAMED15-153-02 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08680829212161 EUDAMED
- Basic UDI-DI
- 0868082921DRPGWNFX EUDAMED
- Direct Marketing DI
- 08680829212161 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
U Split 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 c1283a0b-975b-4916-95a5-5121416e0cb9 61 fields · synced Oct 6, 2026