← Back to catalogue
Bunge Evisceration Spoon Small 13.5 cm - 5 1/4" Stainless Steel
EUDAMEDClass I (EU MDR)
Ref OP-800-01
Identity
- Trade Name
- Bunge Evisceration Spoon Small 13.5 cm - 5 1/4" Stainless Steel EUDAMED
- Device Name
- Cutting Instruments EUDAMED
- Model / Reference
- OP-800-01 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 05055445958268 EUDAMED
- Basic UDI-DI
- 50554459CUTTINGINSTRL2 EUDAMED
- EMDN Code
- L1703 OPHTHALMOLOGY CURETTES, REUSABLE EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Spain EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Implantable
No
EUDAMED
Reusable
Yes
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
Category: Ophthalmic curette, reusable
Bunge Evisceration Spoon Small 13.5 cm - 5 1/4" Stainless Steel by Surtex Instruments Ltd — Class I — MDR — listed in EUDAMED — regulatory data on deviCERTS
Similar devices
Also classified as Ophthalmic curette, reusable.
- S.C.A — SAMSUN CERRAHİ ALETLER SANAYİ VE TİCARET LİMİTED ŞİRKETİ · Class I
- Ambler Surgical — Ambler Surgical, LLC · Class I
- Sklar® — Sklar Corporation · Class I
- Curette — Koros USA, Inc. · Class I
- ASELTECH — Asel Tibbi Aletler A.S. · Class I
- BOSS Instruments — Boss Instruments, Ltd. · Class I
- Curette — Katena Products, Inc. · Class I
- Comfort Plus Curette — Koros USA, Inc. · Class I
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 | 50554459CUTTINGINSTRL2 | Class I | Active |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Surtex Instruments Ltd
- EUDAMED SRN
- GB-MF-000023183
- Authorised Representative
- CMC Medical Devices & Drugs SL ES-AR-000000293
Sources (1)
- EUDAMED 2c4f08ce-fbe4-4e16-9fab-4588a09ba573 61 fields · synced Oct 6, 2026