Identity
- Trade Name
- Bougie Dilator Sets EUDAMED
- Device Name
- Bougie Dilator Sets EUDAMED
- Model / Reference
- HM/302 EUDAMEDHM/302-13 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06951862291898 EUDAMED
- Basic UDI-DI
- B-06951862291898 EUDAMED
- EMDN Code
- G010101 OESOPHAGEAL BOUGIES EUDAMEDG010102 CARDIAS DILATATION TUBES 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-06951862291898 | 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 (2)
- EUDAMED 1c807cb2-5ce5-47d8-8017-d26760357250 61 fields · synced Oct 8, 2026
- EUDAMED 0689ce65-4b8b-438b-990f-ad7933a31518 61 fields · synced Jun 19, 2026