Identity
- Device Name
- mesh fixation device EUDAMED
- Model / Reference
- EHF0115 EUDAMED/ EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06972961596417 EUDAMED
- Basic UDI-DI
- B-06972961596417 EUDAMED
- EMDN Code
- H0299 MECHANICAL SURGICAL STAPLERS - OTHER EUDAMED
Classification
- Device Class
- Class IIb EUDAMED
- Market of Registration
- Poland EUDAMED
Clinical & Handling
Sterile
Yes
EUDAMED
Implantable
Yes
EUDAMED
Reusable
No
EUDAMED
Contains Latex
No
EUDAMED
Reprocessed
No
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
mesh fixation device by BioHealth Medical Technology Co.Ltd. — Class IIb — 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-06972961596417 | Class IIb | Active |
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Manufacturer
- Manufacturer
- BioHealth Medical Technology Co.Ltd.
- EUDAMED SRN
- CN-MF-000000796
- Authorised Representative
- Lotus NL B.V. NL-AR-000000121
Sources (1)
- EUDAMED 67e86077-6ef0-4dd8-930c-c44570d28436 61 fields · synced Jun 18, 2026