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Surgical Cap
EUDAMEDClass I (EU MDR)
Ref 68-1040-BRef 68-1041-BRef 68-1115-BRef 68-1118-BRef 68-1801-BRef 68-1037-RRef 68-1116-B
Identity
- Trade Name
- Surgical Cap EUDAMED
- Device Name
- Surgical Cap EUDAMED
- Model / Reference
- 68-1040-B EUDAMED68-1041-B EUDAMED68-1115-B EUDAMED68-1118-B EUDAMED68-1801-B EUDAMED68-1037-R EUDAMED68-1116-B EUDAMED
Identifiers
- Primary DI / UDI-DI
- 74895237101249 EUDAMED74895237101256 EUDAMED74895237101188 EUDAMED74895237101232 EUDAMED74895237101218 EUDAMED74895237101195 EUDAMED74895237101201 EUDAMED
- Basic UDI-DI
- 48952371509W2 EUDAMED
- EMDN Code
- T0207 CAPS AND HEADWEAR (EXCLUDING PERSONAL PROTECTIVE EQUIPMENT - PPE) EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Germany EUDAMED
Clinical & Handling
Sterile
No
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
Surgical Cap by Kenpax International Limited — 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 | 48952371509W2 | Class I | Active |
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Manufacturer
- Manufacturer
- Kenpax International Limited
- EUDAMED SRN
- HK-MF-000021152
- Authorised Representative
- MedPath GmbH DE-AR-000000087
Sources (7)
- EUDAMED 02ada9b5-72ca-400c-861f-381a08a332e0 61 fields · synced Sep 17, 2026
- EUDAMED cb3be06d-8b6c-451b-9cf5-3f888aaacc85 61 fields · synced May 16, 2026
- EUDAMED 420574e9-3ccb-4986-a379-5366bfdb50ec 61 fields · synced May 17, 2026
- EUDAMED 1ef767fb-58aa-4adb-9f18-917c5ea44b45 61 fields · synced May 18, 2026
- EUDAMED 16fc3881-0ef2-420c-b592-5d8f2c1b0d34 61 fields · synced May 18, 2026
- EUDAMED 7dd767dd-7439-4aca-b8e3-4d70e480a894 61 fields · synced May 18, 2026
- EUDAMED 88674d7c-b158-4e41-a2dc-b413b249d9cf 61 fields · synced May 18, 2026