Identity
- Trade Name
- Sterile Rectal tube EUDAMED
- Device Name
- Sterile Rectal tube EUDAMED
- Model / Reference
- FR28 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06957933255035 EUDAMED
- Basic UDI-DI
- B-06957933255035 EUDAMED
- EMDN Code
- G020301 RECTAL TUBES EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Market of Registration
- Italy EUDAMED
Clinical & Handling
Sterile
Yes
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
Sterile Rectal tube by Changzhou Chuangjia Medical Appliance Co., Ltd. — Class IIa — MDD — listed in EUDAMED — regulatory data on deviCERTS
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/MDD
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDD | B-06957933255035 | Class IIa | Active |
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Manufacturer
- Manufacturer
- Changzhou Chuangjia Medical Appliance Co., Ltd.
- EUDAMED SRN
- CN-MF-000026071
- Authorised Representative
- Lotus NL B.V. NL-AR-000000121
Sources (1)
- EUDAMED 3fa9a5e0-9d11-4010-bb4f-afeaeb1742c6 61 fields · synced Jun 19, 2026