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Heat-sealing Flat Sterilization Reels
EUDAMEDClass I (EU MDR)
Ref 1A8143 150mmx200mmModel 1A8100 1A8101 1A8102 1A8103 1A8104 1A8105 1A8106 1A8107 Ref 1A8142 100mmx200mmRef 1A8141 75mmx200mm Ref 1A8145,200mmx200m,1roll/box, 2box/ctn
Identity
- Trade Name
- Heat-sealing Flat Sterilization Reels EUDAMED
- Device Name
- Self-sealing Sterilization Pouch EUDAMED
- Model / Reference
- 1A8100 1A8101 1A8102 1A8103 1A8104 1A8105 1A8106 1A8107 EUDAMED1A8143 150mmx200mm EUDAMED1A8142 100mmx200mm EUDAMED1A8141 75mmx200mm EUDAMED1A8145,200mmx200m,1roll/box, 2box/ctn EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06977493109302 EUDAMED06977493109296 EUDAMED06977493109289 EUDAMED06977493109326 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
Heat-sealing Flat Sterilization Reels 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 (5)
- EUDAMED d4d60b1f-1057-4019-a626-da35e52d8240 61 fields · synced Jul 21, 2026
- EUDAMED f22bfffc-2521-455e-b06a-de4a9374160f 61 fields · synced May 17, 2026
- EUDAMED f29c2b7d-d1e7-43e2-9c5a-10d77a47c6e7 61 fields · synced May 18, 2026
- EUDAMED b510090c-d945-4ee2-9db0-d6a2c76651f4-1 61 fields · synced Jul 17, 2026
- EUDAMED b510090c-d945-4ee2-9db0-d6a2c76651f4-2 61 fields · synced Jul 17, 2026