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Small Steam Sterilizers
EUDAMEDClass IIb (EU MDR)
Ref IFU-BES-01Model BES23LRef 604Model BES23L,BES18L,BES16L,BES12L,BES8L,CAL23L, CAL18L,CAL16L,CAL12L,CAL8LRef 650Model BES8LRef 662Ref 665
Identity
- Trade Name
- BES23L EUDAMEDBES8L EUDAMEDCAL12L EUDAMEDCAL23L EUDAMED
- Device Name
- Small Steam Sterilizers EUDAMED
- Model / Reference
- BES23L EUDAMEDIFU-BES-01 EUDAMEDBES23L,BES18L,BES16L,BES12L,BES8L,CAL23L, CAL18L,CAL16L,CAL12L,CAL8L EUDAMED604 EUDAMED650 EUDAMEDBES8L EUDAMED662 EUDAMED665 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06975006956047 EUDAMED06975006956504 EUDAMED06975006956627 EUDAMED06975006956658 EUDAMED
- Basic UDI-DI
- B-06975006956047 EUDAMED697500695BES002D6 EUDAMEDB-06975006956504 EUDAMED
- Direct Marketing DI
- 06975006956047 EUDAMED06975006956504 EUDAMED06975006956627 EUDAMED06975006956658 EUDAMED
- EMDN Code
- Q010399 SURGICAL DENTAL DEVICES - OTHER EUDAMEDZ12011305 SMALL LOAD AUTOCLAVES WITH A CHAMBER SMALLER THAN 1 STANDARD STERILISATION UNIT EUDAMED
Classification
- Device Class
- Class IIb EUDAMEDClass IIa EUDAMED
- Market of Registration
- Netherlands EUDAMEDGermany EUDAMED
Clinical & Handling
Sterile
No
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
Small Steam Sterilizers by Ningbo Youjoy Dental Equipment Co., Ltd. — Class IIb — MDR, MDD — listed in EUDAMED — regulatory data on deviCERTS
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/MDR
European Union Active
CE/MDD
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | B-06975006956047 | Class IIb | Active |
| EUDAMED | European Union | CE/MDD | B-06975006956047 | Class IIb | Active |
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Manufacturer
- Manufacturer
- Ningbo Youjoy Dental Equipment Co., Ltd.
- EUDAMED SRN
- CN-MF-000040566
- Authorised Representative
- SUNGO Europe B.V. NL-AR-000000247
Sources (8)
- EUDAMED e0b1d64d-ae2a-44b0-85d5-fb6b65ed91ce 61 fields · synced Jul 20, 2026
- EUDAMED 5565b89b-a747-4937-94cb-5947176a53e0 61 fields · synced May 18, 2026
- EUDAMED 02bd4247-d23e-499b-8e61-31ebe8c8199b 61 fields · synced May 18, 2026
- EUDAMED a161805c-6d6e-4a7e-bb9d-7945b922440d 61 fields · synced May 19, 2026
- EUDAMED 0a057f29-16d3-423f-9daa-f3fbcfe3633e 61 fields · synced Jul 9, 2026
- EUDAMED 3b7dc85c-94f1-46e0-b930-7e4a87136775 61 fields · synced Jul 12, 2026
- EUDAMED 97b9ae91-862a-4142-9ede-44e7d1e05f2c 61 fields · synced Jul 17, 2026
- EUDAMED 7fcd57e7-0303-48cd-a959-798e68973e7c 61 fields · synced Jul 20, 2026