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Reinforced Surgical Gown With Wrapping Size:xl
EUDAMEDClass I (EU MDR)
Ref 16-042-04-KModel STANDARD SURGICAL GOWNRef 17-162-04
Identity
- Trade Name
- REINFORCED SURGICAL GOWN WITH WRAPPING SIZE:XL EUDAMEDREINFORCED GOWN XL EUDAMED
- Device Name
- STERILE DISPOSABLE SURGICAL GOWNS Small EUDAMEDPATIENT GOWN (SHORT SLEEVED) S EUDAMED
- Model / Reference
- STANDARD SURGICAL GOWN EUDAMED16-042-04-K EUDAMED17-162-04 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08680829210754 EUDAMED08680829219924 EUDAMED
- Basic UDI-DI
- 0868082921DRPGWNFX EUDAMED868082921NS0013FE EUDAMED
- Direct Marketing DI
- 08680829210754 EUDAMED08680829219924 EUDAMED
- EMDN Code
- T020402 REINFORCED SURGICAL GOWNS EUDAMEDT0205 NON-SURGICAL GOWNS (EXCLUDING PERSONAL PROTECTIVE EQUIPMENT - PPE) EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Bulgaria EUDAMEDTürkiye EUDAMED
Clinical & Handling
Sterile
Yes
EUDAMEDEUDAMED
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
Reinforced Surgical Gown With Wrapping Size:xl 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 (2)
- EUDAMED 4671c65a-e1bb-440b-a485-d7e9938242d6 61 fields · synced Oct 7, 2026
- EUDAMED 2e3fef87-800a-406e-b9aa-3e96cbe78d17 61 fields · synced Jul 13, 2026