← Back to catalogue
Sterilization Wrap
EUDAMEDFDA 510(k)Class I (EU MDR)
Ref BW3036Ref BW6036Ref BW1024Ref BL1012Ref BW5048Ref BW5036Ref BW1015Ref BL4018Ref BW3024Ref BL1018
Identity
- Trade Name
- Sterilization Wrap EUDAMED
- Device Name
- Sterilization Wrap EUDAMED
- Model / Reference
- BW3036 EUDAMEDBW6036 EUDAMEDBW1024 EUDAMEDBL1012 EUDAMEDBW5048 EUDAMEDBW5036 EUDAMEDBW1015 EUDAMEDBL4018 EUDAMEDBW3024 EUDAMEDBL1018 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 74895237112412 EUDAMED74895237112467 EUDAMED74895237112344 EUDAMED74895237112351 EUDAMED74895237112450 EUDAMED74895237112443 EUDAMED74895237112337 EUDAMED74895237112429 EUDAMED74895237112405 EUDAMED74895237112375 EUDAMED
- Basic UDI-DI
- 48952371515VV EUDAMED
- EMDN Code
- S010302 NON-WOVEN FABRIC FOR STERILISATION 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
Sterilization Wrap by Kenpax International Limited — Class I — FDA_510K, MDR — listed in EUDAMED, FDA 510(k) — regulatory data on deviCERTS
Authorization Coverage (2 countries)
Regulatory Authorizations
United States Active
FDA_510K
European Union Active
CE/MDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K222151 | Class I | Active |
| EUDAMED | European Union | CE/MDR | 48952371515VV | Class I | Active |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Kenpax International Limited
- EUDAMED SRN
- HK-MF-000021152
- Authorised Representative
- MedPath GmbH DE-AR-000000087
Sources (11)
- EUDAMED 16432052-fa8e-4385-a63d-db9099fa5b81 61 fields · synced Aug 4, 2026
- EUDAMED c3c8194f-cd62-43e6-ae42-c48e3a781de0 61 fields · synced May 16, 2026
- EUDAMED 65836492-54b2-4ad7-b8bf-9a6fed68588e 61 fields · synced May 17, 2026
- EUDAMED a7f637bd-925b-4a47-890f-da4fec9e7769 61 fields · synced May 17, 2026
- EUDAMED 163eed9e-1589-4230-b37f-53c23c80b0b3 61 fields · synced May 18, 2026
- EUDAMED 3dd94efd-3904-4489-835f-034b97e43d38 61 fields · synced May 18, 2026
- EUDAMED 3247717b-16a7-4ebb-8ce3-fb263abfa7c2 61 fields · synced May 18, 2026
- EUDAMED 1a240043-3692-4193-801b-0aa0d9beb030 61 fields · synced May 19, 2026
- EUDAMED 6dccc692-7fc5-47ad-97b0-a8d89338a3d7 61 fields · synced May 19, 2026
- EUDAMED 91594b6e-9d38-4260-bb95-1c23b35c4cd0 61 fields · synced May 19, 2026
- FDA 510(k) K222151 1 fields · synced May 18, 2026