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NEODRAP® Perineal Surgical Intervention Set 18AB
EUDAMEDClass I (EU MDR)
Ref KIT-018ABModel Clothing, draping and care sets NEODRAP
by Adhe-Els SA.
Identity
- Trade Name
- NEODRAP® Perineal Surgical Intervention Set 18AB EUDAMED
- Device Name
- NEODRAP® Perineal Surgical Intervention Set 18AB EUDAMED
- Model / Reference
- Clothing, draping and care sets NEODRAP EUDAMEDKIT-018AB EUDAMED
Identifiers
- Primary DI / UDI-DI
- D-KIT-018ABZ7 EUDAMED
- Basic UDI-DI
- B-KIT-018ABZ7 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® Perineal Surgical Intervention Set 18AB 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-018ABZ7 | 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 4724b39c-bf46-442b-ac7e-7f4a8e56ba06 61 fields · synced Jun 18, 2026