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Single-use Stone Retrieval Balloon Catheter
EUDAMEDClass IIa (EU MDR)
Ref KBTD-23-12-15-18
Identity
- Device Name
- Single-use Stone Retrieval Balloon Catheter EUDAMED
- Model / Reference
- KBTD-23-12-15-18 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06948318987986 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 c70a0eb5-9188-4e4b-9263-5448a582a558 61 fields · synced Jun 18, 2026
- EUDAMED 194db82c-d151-4eb4-92e1-f6020204dc2d 61 fields · synced Jun 18, 2026