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ORO STERILIZATION POUCH MEDICAL GRADE SELF SEAL 57x100MM
EUDAMEDClass I (EU MDR)
Ref RPMS57X100
Identity
- Trade Name
- ORO STERILIZATION POUCH MEDICAL GRADE SELF SEAL 57x100MM EUDAMED
- Device Name
- Sterilization Wraps EUDAMED
- Model / Reference
- RPMS57X100 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 89061123269658 EUDAMED
- Basic UDI-DI
- 890611232RPMSJA EUDAMED
- EMDN Code
- S01010101 STERILISATION POUCHES, FLAT, PAPER/PLASTIC FILM EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Belgium 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
ORO STERILIZATION POUCH MEDICAL GRADE SELF SEAL 57x100MM by Reach Global India Pvt. 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 | 890611232RPMSJA | Class I | Active |
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Manufacturer
- Manufacturer
- Reach Global India Pvt. Ltd.
- EUDAMED SRN
- IN-MF-000041886
- Authorised Representative
- CMC Medical Devices & Drugs SL ES-AR-000000293
Sources (1)
- EUDAMED d446c389-a60d-42f2-ba63-9c5b5a9ef601 61 fields · synced Aug 2, 2026