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mesh fixation device
EUDAMEDClass IIb (EU MDR)
Ref /Model EHF0220Model EHF0205Model EHF0230Model EHF0225Model EHF0210Model EHF0215
Identity
- Device Name
- mesh fixation device EUDAMED
- Model / Reference
- EHF0220 EUDAMED/ EUDAMEDEHF0205 EUDAMEDEHF0230 EUDAMEDEHF0225 EUDAMEDEHF0210 EUDAMEDEHF0215 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06972961596486 EUDAMED06972961596455 EUDAMED06972961596509 EUDAMED06972961596493 EUDAMED06972961596462 EUDAMED06972961596479 EUDAMED
- Basic UDI-DI
- B-06972961596486 EUDAMEDB-06972961596455 EUDAMEDB-06972961596509 EUDAMEDB-06972961596493 EUDAMEDB-06972961596462 EUDAMEDB-06972961596479 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-06972961596486 | 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 (6)
- EUDAMED 6f8cc9eb-73e4-488d-8ef8-7818b1bcefa9 61 fields · synced Sep 18, 2026
- EUDAMED 29044a0b-fe42-44b6-aa2c-78202a97d2bb 61 fields · synced May 18, 2026
- EUDAMED fd76b949-b7e7-47d7-838c-f61f006f2b41 61 fields · synced May 18, 2026
- EUDAMED 9e4c2aef-3170-4fd5-9170-12c2840e119d 61 fields · synced May 18, 2026
- EUDAMED e957781a-45d4-4aa5-89f4-410361bd151f 61 fields · synced May 19, 2026
- EUDAMED b3ad2dd5-f347-4a14-91bb-7c1878f0f8d6 61 fields · synced May 19, 2026