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NEODRAP® Surgical gowns set
EUDAMEDClass I (EU MDR)
Ref KIT-003AModel NEODRAP® Surgical gowns set
by Adhe-Els SA.
Identity
- Trade Name
- NEODRAP® Surgical gowns set EUDAMED
- Device Name
- NEODRAP® Surgical gowns set EUDAMED
- Model / Reference
- NEODRAP® Surgical gowns set EUDAMEDKIT-003A EUDAMED
Identifiers
- Primary DI / UDI-DI
- D-KIT-003AC6 EUDAMED
- Basic UDI-DI
- B-KIT-003AC6 EUDAMED
- EMDN Code
- T0203 DRESSING AND ASSISTANCE KITS EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- France EUDAMED
Clinical & Handling
Sterile
Yes
EUDAMED
Implantable
No
EUDAMED
Reusable
No
EUDAMED
Contains Latex
No
EUDAMED
Reprocessed
Yes
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
NEODRAP® Surgical gowns set by Adhe-Els SA. — Class I — MDD — listed in EUDAMED — regulatory data on deviCERTS
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/MDD
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDD | B-KIT-003AC6 | Class I | Active |
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Manufacturer
- Manufacturer
- Adhe-Els SA.
- EUDAMED SRN
- TN-MF-000011757
- Authorised Representative
- ADHE-ELS FRANCE FR-AR-000001654
Sources (1)
- EUDAMED ead99547-e7ae-4ac5-b0e0-9873d99dbe8f 61 fields · synced Aug 4, 2026