← Back to catalogue
Ultraspec Screening Speculum Medium w/o Ratchet
EUDAMEDClass I (EU MDR)
Ref 9128Ref 9129
Identity
- Trade Name
- Ultraspec Screening Speculum Medium w/o Ratchet EUDAMED
- Device Name
- Non sterile speculums EUDAMED
- Model / Reference
- 9128 EUDAMED9129 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 05010058091283 EUDAMED05010058091290 EUDAMED
- Basic UDI-DI
- 5010058CInT047G00APE EUDAMED
- EMDN Code
- U089006 VAGINAL SPECULUM, SINGLE-USE 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
Ultraspec Screening Speculum Medium w/o Ratchet by Robinson Healthcare 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 | 5010058CInT047G00APE | Class I | Active |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Robinson Healthcare Ltd
- EUDAMED SRN
- GB-MF-000016546
- Authorised Representative
- Advena Limited MT-AR-000000234
Sources (2)
- EUDAMED 7b6b0ad7-3246-4f36-a1a8-724b1a4923ef 61 fields · synced Jul 23, 2026
- EUDAMED c05ca72c-a05d-4f7a-a94e-36ea26e68a7e 61 fields · synced May 19, 2026