Identity
- Trade Name
- Orbis EUDAMED
- Device Name
- Self Seal Sterilisation Pouches EUDAMED
- Model / Reference
- Self Seal Sterilisation Pouches EUDAMED88017 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 05060660611676 EUDAMED
- Basic UDI-DI
- 506066061TFPP002C6 EUDAMED
- EMDN Code
- S01010101 STERILISATION POUCHES, FLAT, PAPER/PLASTIC FILM EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Ireland 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
Orbis by Perfection Plus — 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 | 506066061TFPP002C6 | Class I | Active |
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Manufacturer
- Manufacturer
- Perfection Plus
- EUDAMED SRN
- GB-MF-000023781
- Authorised Representative
- Advena Limited MT-AR-000000234
Sources (1)
- EUDAMED 241cf8e3-416e-4aa1-abae-21331c63c5c5 61 fields · synced Jun 19, 2026