Identity
- Device Name
- Dilators EUDAMED
- Model / Reference
- 5 EUDAMED6×700 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06941173328369 EUDAMED
- Basic UDI-DI
- B-06941173328369 EUDAMED
- EMDN Code
- G010101,G010102 EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Austria 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
Dilators by Jiangsu BANA Medical Technology Co., Ltd. — Class I — 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-06941173328369 | Class I | Active |
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Manufacturer
- Manufacturer
- Jiangsu BANA Medical Technology Co., Ltd.
- EUDAMED SRN
- CN-MF-000025963
- Authorised Representative
- Caretechion GmbH DE-AR-000005946
Sources (1)
- EUDAMED 4b20fef4-94b1-4c87-b811-a9bae7a04058 61 fields · synced Jun 19, 2026