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Sterilization Pouches
EUDAMEDClass I (EU MDR)
Ref Self-Sealing Sterilization Pouch
Identity
- Trade Name
- STERILIZATION POUCHES EUDAMED
- Device Name
- STERILIZATION POUCHES EUDAMED
- Model / Reference
- Self-Sealing Sterilization Pouch EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06978502823622 EUDAMED06978502823516 EUDAMED06978502823653 EUDAMED06978502823509 EUDAMED06978502823639 EUDAMED06978502823615 EUDAMED06978502823578 EUDAMED06978502823493 EUDAMED06978502823592 EUDAMED06978502823608 EUDAMED
- Basic UDI-DI
- 697565200SP001HX EUDAMED
- EMDN Code
- Q010599 DENTAL INSTRUMENTS, SINGLE-USE - OTHER EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Germany EUDAMED
Clinical & Handling
Sterile
Yes
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
Sterilization Pouches by Hubei Guarddent 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 | 697565200SP001HX | Class I | Active |
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Manufacturer
- Manufacturer
- Hubei Guarddent Medical Technology Co., Ltd
- EUDAMED SRN
- CN-MF-000028116
- Authorised Representative
- RIOMAVIX SOCIEDAD LIMITADA ES-AR-000001202
Sources (10)
- EUDAMED 9ca662e0-02d2-409b-8731-cacf135b9492 61 fields · synced Oct 6, 2026
- EUDAMED e9108e98-9624-4fcf-a696-e2ef5a688430 61 fields · synced May 16, 2026
- EUDAMED ef0df9af-88a4-40b5-8bc7-b45ceaae7d25 61 fields · synced May 17, 2026
- EUDAMED 9da6e745-3bd4-4eab-9bae-74796624f429 61 fields · synced May 17, 2026
- EUDAMED 6a717cae-8d5c-4413-b1d6-b96902d176b4 61 fields · synced May 17, 2026
- EUDAMED 6470e9fb-949c-49c0-a9c6-9c381aa72a2f 61 fields · synced May 17, 2026
- EUDAMED b573cf35-db04-43da-83c6-9571f6b75220 61 fields · synced May 17, 2026
- EUDAMED ef276b79-923b-4331-a22b-767ccc2ed17a 61 fields · synced May 19, 2026
- EUDAMED 06a6d61f-9ff0-450f-942c-e0d8143f240e 61 fields · synced May 19, 2026
- EUDAMED 36c1d45c-32d4-48af-8377-a4892c9c283e 61 fields · synced May 19, 2026