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Single-use Stone Retrieval Balloon Catheter
EUDAMEDClass IIa (EU MDR)
Ref LBQD-23-12Ref LBQD-23-09-12-15Ref KBQD-23-18Ref RBTP-23-09Ref LBTP-23-18Ref KBQP-23-18Ref RBQD-23-15-18-20Ref RBTD-23-12-15-18Ref KBQD-23-20Ref RBQD-23-12-15-18Ref LBTD-23-12Ref RBQP-23-15Ref LBTD-23-18Ref RBTD-23-09-12-15Ref RBQP-23-15-18-20Ref LBQD-23-15Ref LBQD-23-12-15-18Ref RBQD-23-15Ref KBTD-23-09-12-15Ref RBTD-23-15Ref RBTP-23-20Ref KBQP-23-15Ref RBQP-23-20Ref LBQP-23-12-15-18Ref LBTD-23-12-15-18Ref KBQD-23-15Ref KBQD-23-09-12-15Ref KBTD-23-15
Identity
- Device Name
- Single-use Stone Retrieval Balloon Catheter EUDAMED
- Model / Reference
- LBQD-23-12 EUDAMEDLBQD-23-09-12-15 EUDAMEDKBQD-23-18 EUDAMEDRBTP-23-09 EUDAMEDLBTP-23-18 EUDAMEDKBQP-23-18 EUDAMEDRBQD-23-15-18-20 EUDAMEDRBTD-23-12-15-18 EUDAMEDKBQD-23-20 EUDAMEDRBQD-23-12-15-18 EUDAMEDLBTD-23-12 EUDAMEDRBQP-23-15 EUDAMEDLBTD-23-18 EUDAMEDRBTD-23-09-12-15 EUDAMEDRBQP-23-15-18-20 EUDAMEDLBQD-23-15 EUDAMEDLBQD-23-12-15-18 EUDAMEDRBQD-23-15 EUDAMEDKBTD-23-09-12-15 EUDAMEDRBTD-23-15 EUDAMEDRBTP-23-20 EUDAMEDKBQP-23-15 EUDAMEDRBQP-23-20 EUDAMEDLBQP-23-12-15-18 EUDAMEDLBTD-23-12-15-18 EUDAMEDKBQD-23-15 EUDAMEDKBQD-23-09-12-15 EUDAMEDKBTD-23-15 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06926839808676 EUDAMED06926839808652 EUDAMED06948318987702 EUDAMED06948318965854 EUDAMED06926839808799 EUDAMED06948318987788 EUDAMED06948318965687 EUDAMED06948318965830 EUDAMED06948318987719 EUDAMED06948318965670 EUDAMED06926839808737 EUDAMED06948318965717 EUDAMED06926839808751 EUDAMED06948318965823 EUDAMED06948318965762 EUDAMED06926839808683 EUDAMED06926839808669 EUDAMED06948318965632 EUDAMED06948318987979 EUDAMED06948318965793 EUDAMED06948318965892 EUDAMED06948318987771 EUDAMED06948318965731 EUDAMED06926839808713 EUDAMED06926839808775 EUDAMED06948318987696 EUDAMED06948318987726 EUDAMED06948318987948 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 (56)
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