Identity
- Trade Name
- MED4U EUDAMED
- Device Name
- Sterilization Pouch/Reel EUDAMED
- Model / Reference
- 57mm*130mm EUDAMED90mm*260mm EUDAMED90mm*165mm EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06975434531007 EUDAMED06975434531021 EUDAMED06975434531014 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
Med4u 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 (3)
- EUDAMED 7afbef2f-0c07-4ca0-b45c-94c8e84590c1 61 fields · synced Jul 15, 2026
- EUDAMED 3858705a-d4d7-45de-af87-73dcc70f7368 61 fields · synced May 17, 2026
- EUDAMED 7bbbc6cc-762b-4751-bc8c-11086d6a8f23 61 fields · synced May 18, 2026