Identity
- Trade Name
- Amplatz Sheath EUDAMED
- Device Name
- Percutaneous Dilators EUDAMED
- Model / Reference
- BAST02201701 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08905080010685 EUDAMED
- Basic UDI-DI
- 8905080BPDGH EUDAMED
- EMDN Code
- U03010101 AMPLATZ CANNULAS FOR URINARY DILATION EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Market of Registration
- Czechia EUDAMED
Clinical & Handling
Sterile
Yes
EUDAMED
Implantable
No
EUDAMED
Reusable
No
EUDAMED
Contains Latex
No
EUDAMED
Reprocessed
No
EUDAMED
CMR Substance
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Endocrine Disruptor
No
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
Amplatz Sheath by Blue Neem Medical Devices Private Limited — Class IIa — MDR — listed in EUDAMED — regulatory data on deviCERTS
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/MDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 8905080BPDGH | Class IIa | Active |
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Manufacturer
- Manufacturer
- Blue Neem Medical Devices Private Limited
- EUDAMED SRN
- IN-MF-000021793
- Authorised Representative
- Arazy Group (Ireland) Ltd. IE-AR-000000093
Sources (1)
- EUDAMED 994fa15d-ecd2-4cac-8583-e9f0a8eedfe8 61 fields · synced Oct 6, 2026