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Ostomy Belt/Abdominal Ostomy Support
EUDAMEDClass I (EU MDR)
Ref OB-SF-611 SModel Ostomy Belt - Ostomy SupportRef OB-SF-611 XLRef OB-SF-611 LRef OB-SF-611 XXL
Identity
- Trade Name
- Ostomy Belt/Abdominal Ostomy Support EUDAMED
- Device Name
- Ostomy Belt/Ostomy Support EUDAMED
- Model / Reference
- Ostomy Belt - Ostomy Support EUDAMEDOB-SF-611 S EUDAMEDOB-SF-611 XL EUDAMEDOB-SF-611 L EUDAMEDOB-SF-611 XXL EUDAMED
Identifiers
- Primary DI / UDI-DI
- 04719961661538 EUDAMED04719961661569 EUDAMED04719961661552 EUDAMED04719961661576 EUDAMED
- Basic UDI-DI
- 471996166OSTOMYZS EUDAMED
- EMDN Code
- A108006 ABDOMINAL OSTOMY SUPPORT BELTS EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Germany 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
Ostomy Belt/Abdominal Ostomy Support by Irufa Industrial Group 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 | 471996166OSTOMYZS | Class I | Active |
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Manufacturer
- Manufacturer
- Irufa Industrial Group CO., LTD.
- EUDAMED SRN
- TW-MF-000046083
- Authorised Representative
- KHANG BAO INTERNATIONAL KFT HU-AR-000034102
Sources (4)
- EUDAMED e301ca40-a2c3-4e72-ba0f-08008de5babd 61 fields · synced Oct 6, 2026
- EUDAMED 4217904d-af00-4615-880d-0d1fbf509f16 61 fields · synced May 17, 2026
- EUDAMED 0eac53c4-ffcb-4356-8f57-ef2fd7d3e533 61 fields · synced May 18, 2026
- EUDAMED 4fb25c48-9ed3-42fa-8428-87b976af801f 61 fields · synced May 19, 2026