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Dilator
EUDAMEDClass I (EU MDR)
Ref N/AModel UBE-A-KZGQ-XXXX、UBE-A-KZGN-XXXX、UBE-A-KZGS-XXXX、UBE-A-KZGB-XXXX、UBE-A-KZGJ-XXXX、UBE-FD-KZGN-XXXX、UBE-FD-KZGP-XXXX、UBE-FD-KZGS-XXXX、UBE-FD-KZGB-XXXX、UBE-FD-KZGK-XXXX、UBE-FD-KZGJ-XXXX
Identity
- Device Name
- Dilator EUDAMED
- Model / Reference
- UBE-A-KZGQ-XXXX、UBE-A-KZGN-XXXX、UBE-A-KZGS-XXXX、UBE-A-KZGB-XXXX、UBE-A-KZGJ-XXXX、UBE-FD-KZGN-XXXX、UBE-FD-KZGP-XXXX、UBE-FD-KZGS-XXXX、UBE-FD-KZGB-XXXX、UBE-FD-KZGK-XXXX、UBE-FD-KZGJ-XXXX EUDAMEDN/A EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06942455433269 EUDAMED06942455433061 EUDAMED06942455433078 EUDAMED06942455433153 EUDAMED06942455433306 EUDAMED06942455432965 EUDAMED06942455433115 EUDAMED06942455433221 EUDAMED06942455433207 EUDAMED06942455433283 EUDAMED06942455433245 EUDAMED06942455433191 EUDAMED06942455433009 EUDAMED06942455433290 EUDAMED06942455433313 EUDAMED06942455433054 EUDAMED06942455433177 EUDAMED06942455433320 EUDAMED06942455433047 EUDAMED06942455433016 EUDAMED
- Basic UDI-DI
- 69271553BONSS1626U EUDAMED
- Direct Marketing DI
- 06942455433269 EUDAMED06942455433061 EUDAMED06942455433078 EUDAMED06942455433153 EUDAMED06942455433306 EUDAMED06942455432965 EUDAMED06942455433115 EUDAMED06942455433221 EUDAMED06942455433207 EUDAMED06942455433283 EUDAMED06942455433245 EUDAMED06942455433191 EUDAMED06942455433009 EUDAMED06942455433290 EUDAMED06942455433313 EUDAMED06942455433054 EUDAMED06942455433177 EUDAMED06942455433320 EUDAMED06942455433047 EUDAMED06942455433016 EUDAMED
- EMDN Code
- L0925 ORTHOPAEDIC SURGERY DILATORS, REUSABLE EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Austria EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Implantable
No
EUDAMED
Reusable
Yes
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
Dilator by Jiangsu Bonss Medical Technology Co., Ltd. — Class I — 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 | 69271553BONSS1626U | Class I | Active |
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Manufacturer
- Manufacturer
- Jiangsu Bonss Medical Technology Co Ltd
- EUDAMED SRN
- CN-MF-000023743
- Authorised Representative
- Obelis s.a. BE-AR-000000106
Sources (20)
- EUDAMED 027188fe-b498-4fff-b868-b5c4fee616e2 61 fields · synced Oct 6, 2026
- EUDAMED 80d0b61d-bc7a-4abb-8327-bd4e2e3c43a6 61 fields · synced May 16, 2026
- EUDAMED 47cc4d29-4b5f-4f8a-b404-9f35256c42d7 61 fields · synced May 17, 2026
- EUDAMED efd94544-fd9b-4235-9da8-f8976567299a 61 fields · synced May 17, 2026
- EUDAMED e7d9d392-e75a-44d6-9671-e58be4bd04ef 61 fields · synced May 17, 2026
- EUDAMED be383a88-e63c-4ab9-98a5-f9078159650a 61 fields · synced May 17, 2026
- EUDAMED e112f00a-b07a-4497-80df-9b05a3789dca 61 fields · synced May 17, 2026
- EUDAMED 5e11658f-3407-439a-9a9b-b7162ceb16fa 61 fields · synced May 17, 2026
- EUDAMED 6898ce4f-328d-436b-b644-37d2a52624b7 61 fields · synced May 17, 2026
- EUDAMED 023faf3b-8f0d-4f09-82c0-e69da91873b3 61 fields · synced May 18, 2026
- EUDAMED 54eb441f-ec61-4386-af29-e2ab9d213ad0 61 fields · synced May 18, 2026
- EUDAMED 16866ab8-f380-4e90-a0e1-f8d7beb501f7 61 fields · synced May 19, 2026
- EUDAMED 11ee37eb-8365-410b-bb29-6d9fb00b5f0c 61 fields · synced May 19, 2026
- EUDAMED b76f27f3-92a1-43d1-9528-045fcc4b3b1d 61 fields · synced May 19, 2026
- EUDAMED 68f352c7-c6e6-40ab-ac47-8ef623425d53 61 fields · synced May 19, 2026
- EUDAMED a397864e-9dd3-46e1-b715-05babe8e3f0a 61 fields · synced May 19, 2026
- EUDAMED f84fe3bd-7267-4d6d-bd89-4ff5c771f24f 61 fields · synced May 19, 2026
- EUDAMED bf5c0b81-8b8e-4dda-997a-b37b8bfb2acb 61 fields · synced May 19, 2026
- EUDAMED 5181998d-4386-49f2-849b-e61e5caed582 61 fields · synced May 19, 2026
- EUDAMED f3f7b759-beae-4514-b252-e536266d9ed1 61 fields · synced May 19, 2026