Identity
- Device Name
- Sterilization Pouch/Reel EUDAMED
- Model / Reference
- 135mm*260mm EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06975434530093 EUDAMED
- Basic UDI-DI
- 697543453P001H7 EUDAMED
- EMDN Code
- S010199 STERILISATION POUCHES - OTHER EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Poland EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Implantable
No
EUDAMED
Reusable
No
EUDAMED
Contains Latex
No
EUDAMED
Reprocessed
Yes
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
Sterilization Pouch/Reel by Anqing Clean Dental Instrument 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 | 697543453P001H7 | Class I | Active |
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Manufacturer
- Manufacturer
- Anqing Clean Dental Instrument Technology Co., Ltd
- EUDAMED SRN
- CN-MF-000026210
- Authorised Representative
- SUNGO Europe B.V. NL-AR-000000247
Sources (1)
- EUDAMED aa7d928b-0467-4fc8-8b5f-519cf10dd307 61 fields · synced Jun 19, 2026