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Flat Heat-sealing Sterilization Pouch
EUDAMEDFDA 510(k)Class I (EU MDR)
Ref 10cm*25cm
Identity
- Device Name
- Flat Heat-sealing Sterilization Pouch EUDAMED
- Model / Reference
- 10cm*25cm EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06970256841082 EUDAMED
- Basic UDI-DI
- 69702568400048F EUDAMED
- Direct Marketing DI
- 06970256841082 EUDAMED
- EMDN Code
- S01010101 STERILISATION POUCHES, FLAT, PAPER/PLASTIC FILM EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Bulgaria 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
Flat Heat-sealing Sterilization Pouch by Anqing YIPAK Packaging Material Co., Ltd. — Class I — FDA_510K, MDR — listed in EUDAMED, FDA 510(k)
Authorization Coverage (2 countries)
Regulatory Authorizations
United States Active
FDA_510K
European Union Active
CE/MDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K181957 | Class I | Active |
| EUDAMED | European Union | CE/MDR | 69702568400048F | Class I | Active |
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Manufacturer
- Manufacturer
- Anqing YIPAK Packaging Material Co., Ltd.
- EUDAMED SRN
- CN-MF-000025130
- Authorised Representative
- Shanghai International Holding Corp. GmbH(Europe) DE-AR-000000001
Sources (2)
- EUDAMED a54d60c2-1ff5-4b17-bf5b-d338adc1fd16 61 fields · synced Jul 12, 2026
- FDA 510(k) K181957 1 fields · synced May 18, 2026