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Sterilization pouch/roll
EUDAMEDClass I (EU MDR)
Ref N/AModel TOP057100 TOP070260 TOP090165 TOP090260 TOP135280 TOP300430 TOP190360 TOP500630 TOP050200 TOP075200 TOP100200 TOP150200 TOP200200 TOP250200 TOP300200 TOP400200 TOP500200 TOP075100 TOP100100 TOP150100 TOP200100 TOP250100 TOP300100 TOP10070 TOP15070 etc
Identity
- Device Name
- Sterilization pouch/roll EUDAMED
- Model / Reference
- TOP057100 TOP070260 TOP090165 TOP090260 TOP135280 TOP300430 TOP190360 TOP500630 TOP050200 TOP075200 TOP100200 TOP150200 TOP200200 TOP250200 TOP300200 TOP400200 TOP500200 TOP075100 TOP100100 TOP150100 TOP200100 TOP250100 TOP300100 TOP10070 TOP15070 etc EUDAMEDN/A EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06975965240010 EUDAMED
- Basic UDI-DI
- 697596524SP01TQ 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/roll by Anqing Topeak Medical 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 | 697596524SP01TQ | Class I | Active |
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Manufacturer
- Manufacturer
- Anqing Topeak Medical Co., Ltd
- EUDAMED SRN
- CN-MF-000032445
- Authorised Representative
- SUNGO Europe B.V. NL-AR-000000247
Sources (1)
- EUDAMED 14593362-4790-450d-bc89-b43620c9f0dd 61 fields · synced Oct 6, 2026