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surgical mesh
EUDAMEDClass IIb (EU MDR)
Ref /Model EHB0401Model EHA0401Model EHB0303Model EHA0301Model EHA0404Model EHA0411Model EHA0302Model EHB0111Model EHA0305Model EHB0402Model EHA0407Model EHB0411Model EHB0414Model EHB0406Model EHA0412Model EHA0304Model EHB0304Model EHB0109Model EHB0415Model EHB0416Model EHA0106Model EHA0410Model EHA0418Model EHA0415Model EHA0413Model EHA0111Model EHB0301Model EHB0404Model EHB0305Model EHA0307Model EHB0419Model EHB0101Model EHB0106
Identity
- Device Name
- surgical mesh EUDAMED
- Model / Reference
- EHB0401 EUDAMED/ EUDAMEDEHA0401 EUDAMEDEHB0303 EUDAMEDEHA0301 EUDAMEDEHA0404 EUDAMEDEHA0411 EUDAMEDEHA0302 EUDAMEDEHB0111 EUDAMEDEHA0305 EUDAMEDEHB0402 EUDAMEDEHA0407 EUDAMEDEHB0411 EUDAMEDEHB0414 EUDAMEDEHB0406 EUDAMEDEHA0412 EUDAMEDEHA0304 EUDAMEDEHB0304 EUDAMEDEHB0109 EUDAMEDEHB0415 EUDAMEDEHB0416 EUDAMEDEHA0106 EUDAMEDEHA0410 EUDAMEDEHA0418 EUDAMEDEHA0415 EUDAMEDEHA0413 EUDAMEDEHA0111 EUDAMEDEHB0301 EUDAMEDEHB0404 EUDAMEDEHB0305 EUDAMEDEHA0307 EUDAMEDEHB0419 EUDAMEDEHB0101 EUDAMEDEHB0106 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06972961590965 EUDAMED06972961590910 EUDAMED06972961590736 EUDAMED06972961591344 EUDAMED06972961591436 EUDAMED06972961590699 EUDAMED06972961590606 EUDAMED06972961591337 EUDAMED06972961591368 EUDAMED06972961591917 EUDAMED06972961590675 EUDAMED06972961590811 EUDAMED06972961591955 EUDAMED06972961590781 EUDAMED06972961590705 EUDAMED06972961591351 EUDAMED06972961591399 EUDAMED06972961590866 EUDAMED06972961591962 EUDAMED06972961591979 EUDAMED06972961591276 EUDAMED06972961590927 EUDAMED06972961590712 EUDAMED06972961591474 EUDAMED06972961591450 EUDAMED06972961590897 EUDAMED06972961591382 EUDAMED06972961591924 EUDAMED06972961591405 EUDAMED06972961590637 EUDAMED06972961591993 EUDAMED06972961591290 EUDAMED06972961591320 EUDAMED
- Basic UDI-DI
- B-06972961590965 EUDAMEDB-06972961590910 EUDAMEDB-06972961590736 EUDAMEDB-06972961591344 EUDAMEDB-06972961591436 EUDAMEDB-06972961590699 EUDAMEDB-06972961590606 EUDAMEDB-06972961591337 EUDAMEDB-06972961591368 EUDAMEDB-06972961591917 EUDAMEDB-06972961590675 EUDAMEDB-06972961590811 EUDAMEDB-06972961591955 EUDAMEDB-06972961590781 EUDAMEDB-06972961590705 EUDAMEDB-06972961591351 EUDAMEDB-06972961591399 EUDAMEDB-06972961590866 EUDAMEDB-06972961591962 EUDAMEDB-06972961591979 EUDAMEDB-06972961591276 EUDAMEDB-06972961590927 EUDAMEDB-06972961590712 EUDAMEDB-06972961591474 EUDAMEDB-06972961591450 EUDAMEDB-06972961590897 EUDAMEDB-06972961591382 EUDAMEDB-06972961591924 EUDAMEDB-06972961591405 EUDAMEDB-06972961590637 EUDAMEDB-06972961591993 EUDAMEDB-06972961591290 EUDAMEDB-06972961591320 EUDAMED
- EMDN Code
- P900202 POLYPROPYLENE SURGICAL MESHES EUDAMED
Classification
- Device Class
- Class IIb EUDAMED
- Market of Registration
- Poland EUDAMED
Clinical & Handling
Sterile
Yes
EUDAMEDEUDAMED
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
surgical mesh 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-06972961590965 | Class IIb | Active |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- BioHealth Medical Technology Co.Ltd.
- EUDAMED SRN
- CN-MF-000000796
- Authorised Representative
- Lotus NL B.V. NL-AR-000000121
Sources (33)
- EUDAMED 0e9a97eb-ee01-49f6-9e40-3849f82fde08 61 fields · synced Sep 18, 2026
- EUDAMED 2e808b31-de34-4764-91bd-07b3d6b6b639 61 fields · synced May 11, 2026
- EUDAMED 27bf4879-c02d-4bce-804c-263586bd1ce4 61 fields · synced May 16, 2026
- EUDAMED 7744d3dd-1429-41ed-ba51-bbec336bfae0 61 fields · synced May 16, 2026
- EUDAMED 7adf637a-c82c-440b-9f33-f91bc56da5a2 61 fields · synced May 16, 2026
- EUDAMED 9e269753-8c30-4297-92d4-25e997a55d07 61 fields · synced May 16, 2026
- EUDAMED 55a176ad-3d8d-49cc-aa38-fdb43a1a688a 61 fields · synced May 16, 2026
- EUDAMED 46566949-1f68-4949-bb5f-9b3f2aedbc6a 61 fields · synced May 16, 2026
- EUDAMED b969372f-7cf6-4d23-b113-168effb71756 61 fields · synced May 16, 2026
- EUDAMED b76f2ca3-2b04-4b91-bd1d-0fdab54c3a65 61 fields · synced May 16, 2026
- EUDAMED 7934059a-76b0-4786-a949-96d3f3087074 61 fields · synced May 17, 2026
- EUDAMED 8ee3470c-ca4a-4029-9d8e-aa5d3898b2cc 61 fields · synced May 17, 2026
- EUDAMED 1b04f704-f565-4519-af15-38681966aaef 61 fields · synced May 17, 2026
- EUDAMED ad633074-9ed9-4e3b-93e6-8c5ae380b8f8 61 fields · synced May 17, 2026
- EUDAMED 00593de9-e0ff-4910-a21b-8aaf956f4889 61 fields · synced May 17, 2026
- EUDAMED 5d2b41da-110f-4c38-916a-da180e177fbf 61 fields · synced May 17, 2026
- EUDAMED 96755ede-13c3-49c3-ae6c-7af79caa0c7c 61 fields · synced May 17, 2026
- EUDAMED 43fa786b-7c5c-4ae8-9af2-3fc5403e5a8e 61 fields · synced May 17, 2026
- EUDAMED 84d42eb3-c0ba-4a18-ae96-01014e5358a7 61 fields · synced May 17, 2026
- EUDAMED f4943416-b72d-47e4-9432-ebf950383e79 61 fields · synced May 17, 2026
- EUDAMED ad48524f-c88d-4fa5-8edb-df6a732e486f 61 fields · synced May 17, 2026
- EUDAMED 287609f7-d24f-4e0f-9a3a-536f507d1cf5 61 fields · synced May 17, 2026
- EUDAMED fb89ee0b-6065-44bf-a4e2-d80e8c197a24 61 fields · synced May 17, 2026
- EUDAMED 3938f5e8-754a-452b-8041-385028adc462 61 fields · synced May 17, 2026
- EUDAMED 9312a4ac-726e-42d6-b4ff-a6d92ff89e88 61 fields · synced May 18, 2026
- EUDAMED 2da4558c-58ad-4690-bbf7-e1c56704c7be 61 fields · synced May 18, 2026
- EUDAMED c2ee4aa3-0287-4a12-ad67-25433f180857 61 fields · synced May 18, 2026
- EUDAMED 359e5b35-726a-4a68-b409-810073b54ce3 61 fields · synced May 18, 2026
- EUDAMED 3bf742da-48c9-45e2-b993-9cf04f937964 61 fields · synced May 18, 2026
- EUDAMED 89cf46e2-7758-4a92-bc5f-96251a718450 61 fields · synced May 18, 2026
- EUDAMED 507b17b6-6829-420e-b7fd-3dd00e25a347 61 fields · synced May 18, 2026
- EUDAMED 0319c237-8c86-4e14-b354-570e24d24e57 61 fields · synced May 19, 2026
- EUDAMED f5e30e29-d17d-4c37-9dab-303e1468e264 61 fields · synced May 19, 2026