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Single-use Stone Retrieval Balloon Catheter
EUDAMEDClass IIa (EU MDR)
Ref RBQD-23-18
Identity
- Device Name
- Single-use Stone Retrieval Balloon Catheter EUDAMED
- Model / Reference
- RBQD-23-18 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06948318965649 EUDAMED
- Basic UDI-DI
- 694831892a004MB EUDAMED
- EMDN Code
- G03050101 DIGESTIVE ENDOSCOPY, RETRIEVAL BALLOON DEVICES EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Market of Registration
- Croatia EUDAMED
Clinical & Handling
Sterile
Yes
EUDAMED
Implantable
No
EUDAMED
Reusable
No
EUDAMED
Contains Latex
Yes
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
Single-use Stone Retrieval Balloon Catheter by Anrei Medical (HZ) CO., LTD. — 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 | 694831892a004MB | Class IIa | Active |
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Manufacturer
- Manufacturer
- Anrei Medical (HZ) Co., Ltd.
- EUDAMED SRN
- CN-MF-000009964
- Authorised Representative
- Shanghai International Holding Corp. GmbH(Europe) DE-AR-000000001
Sources (2)
- EUDAMED 9996ae88-e8ee-41ea-9c1c-7829593e17a3 61 fields · synced Jun 19, 2026
- EUDAMED 16e47a98-1b6c-46f3-a7e3-956d8d800681 61 fields · synced Jun 14, 2026