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Self-sealing Sterilization Pouch
EUDAMEDClass I (EU MDR)
Ref 1A8105,305x380mm,200pcs/box, 5box/ctnModel 1A8100 1A8101 1A8102 1A8103 1A8104 1A8105 1A8106 1A8107
Identity
- Trade Name
- Self-sealing Sterilization Pouch EUDAMED
- Device Name
- Self-sealing Sterilization Pouch EUDAMED
- Model / Reference
- 1A8100 1A8101 1A8102 1A8103 1A8104 1A8105 1A8106 1A8107 EUDAMED1A8105,305x380mm,200pcs/box, 5box/ctn EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06977493109241 EUDAMED
- Basic UDI-DI
- 697749310010005V6 EUDAMED
- EMDN Code
- S01010101 STERILISATION POUCHES, FLAT, PAPER/PLASTIC FILM EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Cyprus 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
Self-sealing Sterilization Pouch by Shanghai Dochem Industries 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 | 697749310010005V6 | Class I | Active |
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Manufacturer
- Manufacturer
- Shanghai Dochem Industries Co., Ltd.
- EUDAMED SRN
- CN-MF-000014350
- Authorised Representative
- MedNet EC-REP GmbH DE-AR-000000002
Sources (2)
- EUDAMED b874f56c-f301-4c92-9e9a-ff248e1d8f1e-1 61 fields · synced Jun 19, 2026
- EUDAMED b874f56c-f301-4c92-9e9a-ff248e1d8f1e-2 61 fields · synced Jun 19, 2026