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Sterilization Pouch
EUDAMEDClass I (EU MDR)
Ref N/AModel Self-Sealing Sterilization Pouch; Heat-Sealing Sterilization Pouch; Sterilization Flat Reel; Sterilization Gusseted Reel
Identity
- Device Name
- Sterilization Pouch EUDAMED
- Model / Reference
- Self-Sealing Sterilization Pouch; Heat-Sealing Sterilization Pouch; Sterilization Flat Reel; Sterilization Gusseted Reel EUDAMEDN/A EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06975875320000 EUDAMED
- Basic UDI-DI
- 697587532SP001RD EUDAMED
- Direct Marketing DI
- 06975875320000 EUDAMED
- EMDN Code
- S01020101,S01020102,S01020201,S01020301,S010299 EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Austria 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
Sterilization Pouch by Anqing Kangjie P&P Packaging 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 | 697587532SP001RD | Class I | Active |
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Manufacturer
- Manufacturer
- Anqing Kangjie P&P Packaging Co., Ltd.
- EUDAMED SRN
- CN-MF-000030668
- Authorised Representative
- SUNGO Europe B.V. NL-AR-000000247
Sources (2)
- EUDAMED 89ac7543-5741-48ea-b50f-7d52129c1bbf 61 fields · synced Aug 3, 2026
- EUDAMED 89ac7543-5741-48ea-b50f-7d52129c1bbf-1 61 fields · synced Jun 11, 2026