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Sterile Surgical Drapes
EUDAMEDClass I (EU MDR)
Ref 71-3061-SModel Drape; Approach Drape; Foot Drape Self Adhesive; Utility Drape With Tape, 2pcs/pack; Hand Drape Reinforced; Hand Drape Reinforced; Slit Sheet Drape Self Adhesive; Impervious Split Self Adhesive Drape; Shoulder Impervious Split Drape; etc.
Identity
- Trade Name
- Sterile Surgical Drapes EUDAMED
- Device Name
- Sterile Surgical Drapes EUDAMED
- Model / Reference
- Drape; Approach Drape; Foot Drape Self Adhesive; Utility Drape With Tape, 2pcs/pack; Hand Drape Reinforced; Hand Drape Reinforced; Slit Sheet Drape Self Adhesive; Impervious Split Self Adhesive Drape; Shoulder Impervious Split Drape; etc. EUDAMED71-3061-S EUDAMED
Identifiers
- Primary DI / UDI-DI
- 04895237162227 EUDAMED
- Basic UDI-DI
- 48952371003UV EUDAMED
- EMDN Code
- T020199 SURGICAL DRAPES - OTHER EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Germany 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
Sterile Surgical Drapes 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 | 48952371003UV | 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 (1)
- EUDAMED 5ba04818-1722-4f18-917c-9243cac8a026 61 fields · synced Jun 20, 2026