← Back to catalogue
Sheath
EUDAMEDClass A (EU MDR)
Ref Sheath-XN 20LModel Sheath-Sys,Sheath-Ruby,Sheath-XN Ref Sheath-Ruby 10LRef Sheath-sys 10LRef Sheath-XN 5LRef Sheath--sys 5LRef Sheath-Ruby 20LRef Sheath-sys 15L
Identity
- Device Name
- Sheath EUDAMED
- Model / Reference
- Sheath-Sys,Sheath-Ruby,Sheath-XN EUDAMEDSheath-XN 20L EUDAMEDSheath-Ruby 10L EUDAMEDSheath-sys 10L EUDAMEDSheath-XN 5L EUDAMEDSheath--sys 5L EUDAMEDSheath-Ruby 20L EUDAMEDSheath-sys 15L EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06972337857869 EUDAMED06972337857777 EUDAMED06972337857807 EUDAMED06972337857838 EUDAMED06972337857791 EUDAMED06972337851355 EUDAMED06972337857814 EUDAMED
- Basic UDI-DI
- 697233785Sheath022NM EUDAMED
- EMDN Code
- W0103010105 CBC-REAGENTS (CLEANING-/DILUTING-/LYSING-/SHEATH-FLUIDS) EUDAMED
Classification
- Device Class
- Class A EUDAMED
- Market of Registration
- Austria EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Microbial Substances
No
EUDAMED
Reagent
Yes
EUDAMED
Self Testing
No
EUDAMED
Near-Patient Testing
No
EUDAMED
Professional Testing
Yes
EUDAMED
Companion Diagnostics
No
EUDAMED
Surgical Instrument
No
EUDAMED
New Device
No
EUDAMED
Sheath by B&E Bio-Technology Co., Ltd. — Class A — IVDR — listed in EUDAMED — regulatory data on deviCERTS
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/IVDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/IVDR | 697233785Sheath022NM | Class A | Active |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- B&E Bio-Technology Co., Ltd.
- EUDAMED SRN
- CN-MF-000023256
- Authorised Representative
- SUNGO Europe B.V. NL-AR-000000247
Sources (7)
- EUDAMED aace46d2-351c-4d28-a63d-5670e6744070 61 fields · synced Jul 26, 2026
- EUDAMED 3e427ed2-9d70-48d0-8ff3-0ec2322943ac 61 fields · synced May 17, 2026
- EUDAMED ab76bc6b-a346-4850-9f1e-771fba4fa740 61 fields · synced May 17, 2026
- EUDAMED 51ea2420-b1e4-4ed6-9c12-69488021199b 61 fields · synced May 17, 2026
- EUDAMED 4736a859-c737-464c-bded-c1197cecd233 61 fields · synced May 18, 2026
- EUDAMED e9610735-451e-4c2e-9330-5e6b01d0e3ce 61 fields · synced May 19, 2026
- EUDAMED 56fb7f5a-94df-44ad-9572-cbeb512745a4 61 fields · synced May 19, 2026