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Bougie Dilator Sets
EUDAMEDClass IIa (EU MDR)
Ref HM302-20Model HM/302Ref HM302-19Ref HM/302-14Ref HM302-08Ref HM302-10Ref HM302-07Ref HM302-05Ref HM302-17Ref HM302-16Ref HM302-15Ref HM/302-11Ref HM302-09
Identity
- Trade Name
- Bougie Dilator Sets EUDAMED
- Device Name
- Bougie Dilator Sets EUDAMED
- Model / Reference
- HM/302 EUDAMEDHM302-20 EUDAMEDHM302-19 EUDAMEDHM/302-14 EUDAMEDHM302-08 EUDAMEDHM302-10 EUDAMEDHM302-07 EUDAMEDHM302-05 EUDAMEDHM302-17 EUDAMEDHM302-16 EUDAMEDHM302-15 EUDAMEDHM/302-11 EUDAMEDHM302-09 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06951862291966 EUDAMED06951862291959 EUDAMED06951862291904 EUDAMED06951862291843 EUDAMED06951862291867 EUDAMED06951862291836 EUDAMED06951862291812 EUDAMED06951862291935 EUDAMED06951862291928 EUDAMED06951862291911 EUDAMED06951862291874 EUDAMED06951862291850 EUDAMED
- Basic UDI-DI
- B-06951862291966 EUDAMEDB-06951862291959 EUDAMEDB-06951862291904 EUDAMEDB-06951862291843 EUDAMEDB-06951862291867 EUDAMEDB-06951862291836 EUDAMEDB-06951862291812 EUDAMEDB-06951862291935 EUDAMEDB-06951862291928 EUDAMEDB-06951862291911 EUDAMEDB-06951862291874 EUDAMEDB-06951862291850 EUDAMED
- EMDN Code
- G010101 OESOPHAGEAL BOUGIES EUDAMEDG010102 CARDIAS DILATATION TUBES EUDAMEDG010101,G010102 EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Market of Registration
- Germany EUDAMED
Clinical & Handling
Sterile
Yes
EUDAMED
Implantable
No
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
Bougie Dilator Sets by Changzhou Health Microport Medical Device Co., Ltd — Class IIa — 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-06951862291966 | Class IIa | Active |
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Manufacturer
- Manufacturer
- Changzhou Health Microport Medical Device Co., Ltd.
- EUDAMED SRN
- CN-MF-000033536
- Authorised Representative
- Llins Service & Consulting GmbH DE-AR-000009077
Sources (24)
- EUDAMED 0d936bb6-2f89-45e3-aa9a-bedcf5ddd1d0 61 fields · synced Oct 6, 2026
- EUDAMED b7360441-9fd7-4552-8d99-e146b991ed31 61 fields · synced May 16, 2026
- EUDAMED b4f90c86-8c26-4245-82f2-ec0c4da4b7d1 61 fields · synced May 16, 2026
- EUDAMED 3256f989-77c5-456a-94d0-6723754d8269 61 fields · synced May 17, 2026
- EUDAMED f51f90b5-742e-4271-a8df-d4ec12372474 61 fields · synced May 17, 2026
- EUDAMED e17aa454-fa58-494d-a972-8dd79d7c8915 61 fields · synced May 17, 2026
- EUDAMED 92565fef-3aab-4228-8581-00cb14e31cea 61 fields · synced May 17, 2026
- EUDAMED f09b39f6-bbfb-4920-bd1e-65de1836c2a6 61 fields · synced May 18, 2026
- EUDAMED 2db83d80-4a45-4d51-aeca-06af42825c1e 61 fields · synced May 18, 2026
- EUDAMED d17ab7d3-bbed-4121-a77c-2a0bd4f26696 61 fields · synced May 19, 2026
- EUDAMED e76bcec1-edd0-48cb-987b-97eebcdbf56f 61 fields · synced May 19, 2026
- EUDAMED 0fe0fae3-2f3d-464e-80d8-88486c8cb4fb 61 fields · synced May 19, 2026
- EUDAMED 02afbbd1-d932-4487-bb33-28a3e5de29bf 61 fields · synced Jul 11, 2026
- EUDAMED 1fe20dbc-c3e4-4831-97b6-39c3148e0549 61 fields · synced Jul 14, 2026
- EUDAMED 3cbc6b84-8a1d-44e5-b0cb-c63e45f9ab73 61 fields · synced Jul 17, 2026
- EUDAMED 03ccd3b6-2aa4-432f-94aa-e947b6838f52 61 fields · synced Jul 18, 2026
- EUDAMED d621f87b-1dc3-4f0a-bf9a-fa64ae3e546c 61 fields · synced Jul 21, 2026
- EUDAMED eedd6288-981c-4bbf-ad6a-729257da82f7 61 fields · synced Jul 26, 2026
- EUDAMED 2c431681-c9ac-4b9a-ace2-a212850ea549 61 fields · synced Jul 27, 2026
- EUDAMED bb717ece-4bbf-49ed-89bc-816e7d2ba06e 61 fields · synced Jul 28, 2026
- EUDAMED 314da69d-035d-4d9c-85ef-f0812190fbe7 61 fields · synced Jul 29, 2026
- EUDAMED 0b349a1a-9cc8-4148-8d92-e9ba3fdc9bbd 61 fields · synced Jul 29, 2026
- EUDAMED 53670e32-71bf-4b39-a23f-3f46cd490cb1 61 fields · synced Aug 2, 2026
- EUDAMED 5b8838f7-002a-4b7e-bff2-7533b57c4b31 61 fields · synced Aug 3, 2026