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Small Steam Sterilizers
EUDAMEDClass IIb (EU MDR)
Ref IFU-BES-01Model BES12LRef 651Model BES23L,BES18L,BES16L,BES12L,BES8L,CAL23L, CAL18L,CAL16L,CAL12L,CAL8L
Identity
- Trade Name
- BES12L EUDAMED
- Device Name
- Small Steam Sterilizers EUDAMED
- Model / Reference
- BES12L EUDAMEDIFU-BES-01 EUDAMEDBES23L,BES18L,BES16L,BES12L,BES8L,CAL23L, CAL18L,CAL16L,CAL12L,CAL8L EUDAMED651 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06975006956511 EUDAMED
- Basic UDI-DI
- B-06975006956511 EUDAMED697500695BES002D6 EUDAMED
- Direct Marketing DI
- 06975006956511 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-06975006956511 | Class IIb | Active |
| EUDAMED | European Union | CE/MDD | B-06975006956511 | 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 (3)
- EUDAMED 2b76e17f-a805-423c-865d-23564fcafe57 61 fields · synced Jul 9, 2026
- EUDAMED f316cfba-a5fc-45e8-9476-e9541f485128 61 fields · synced May 17, 2026
- EUDAMED f3d88a6b-46eb-4513-aaf4-75105a88de31 61 fields · synced Jun 18, 2026