← Back to catalogue
Disposable EVA Collection Bag 0.5 L
FDA UDIEUDAMEDClass II (US FDA UDI)
Ref 8110.BAG01
by D.O.R.C. Dutch Ophthalmic Research Center (International) B.V.
Identity
- Trade Name
- Disposable EVA Collection Bag 0.5 L EUDAMEDFDA UDI
- Generic Name
- Ophthalmic surgical procedure kit, non-medicated, single-use FDA UDI
- Device Name
- Ophthalmic surgery fluid collection bag EUDAMED
- Model / Reference
- 8110.BAG01 EUDAMEDFDA UDI
Identifiers
- Catalog Number
- 8110.BAG01 FDA UDI
- Primary DI / UDI-DI
- 08717872019154 EUDAMEDFDA UDI
- Basic UDI-DI
- 8717872I12060111BHKNG EUDAMED
- 510(k) Number
- K190875 FDA UDI
- FDA Product Code
- HQC FDA UDIHQE FDA UDI
- EMDN Code
- Z1212020785 PHACO-VITRECTOMY INSTRUMENTS - CONSUMABLES EUDAMED
- GMDN Term
- Ophthalmic surgical procedure kit, non-medicated, single-use FDA UDI
Classification
- Device Class
- Class I EUDAMEDClass II FDA UDI
- Regulation Number
- 886.4670 FDA UDI886.4150 FDA UDI
- Market of Registration
- Netherlands EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
EUDAMEDFDA UDI
Single Use
Yes
FDA UDI
Implantable
No
EUDAMEDFDA UDI
Reusable
No
EUDAMED
Contains Latex
No
EUDAMEDFDA UDI
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
Prescription Use
Yes
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Ophthalmic surgical procedure kit, non-medicated, single-use
Disposable EVA Collection Bag 0.5 L by D.O.R.C. Dutch Ophthalmic Research Center (International) B.V. — Class II — MDR, FDA UDI — listed in FDA GUDID, EUDAMED
Similar devices
Also classified as Ophthalmic surgical procedure kit, non-medicated, single-use.
- 3 POLI-SAFE 60X45 C/ ADESIVO — Linea Sterile S.p.A. · Class I
- CustomEyes® — Beaver-Visitec International, Inc. · Class I
- CARDINAL HEALTH — Cardinal Health 200, LLC · Class II
- LAPAROSCOPIC COLON PACK — Johnson & Johnson Medical GmbH · Class III
- LAPAROSCOPIC SLEEVE RESECTION PACK — Johnson & Johnson Medical GmbH · Class III
- KIT GINECOLOGIA LAPAROSCOPIA — Linea Sterile S.p.A. · Class I
- SET 273 Ambulant — BATIST Medical Productions s.r.o. · Class III
- CARDINAL HEALTH — Cardinal Health 200, LLC · Class II
Cleared under the same submission
K190875 also covers:
- 2.2 mm Reusable phaco set with 30° angled flared needle Note: Maximum 20x reusab — D.O.R.C. Dutch Ophthalmic Research Center (International) B.V.
- 2.2 mm Reusable phaco set with 30° straight flared needle — D.O.R.C. Dutch Ophthalmic Research Center (International) B.V.
- 2.2 mm Reusable phaco set with 45° angled flared needle Note: Maximum 20x reusab — D.O.R.C. Dutch Ophthalmic Research Center (International) B.V.
- 2.2 mm Reusable phaco set with 45° straight flared needle — D.O.R.C. Dutch Ophthalmic Research Center (International) B.V.
- 2.2 mm Triple step angled flared phaco needle. (disposable) — D.O.R.C. Dutch Ophthalmic Research Center (International) B.V.
- 2.2 mm Triple step angled flared phaco needle. (limited reusable 20x) — D.O.R.C. Dutch Ophthalmic Research Center (International) B.V.
- 2.2 mm Triple step flared phaco needle. (limited reusable 20x) — D.O.R.C. Dutch Ophthalmic Research Center (International) B.V.
- 2.5 mm Triple step angled flared phaco needle. (limited reusable 20x) — D.O.R.C. Dutch Ophthalmic Research Center (International) B.V.
- 2.8 mm Disposable phaco set with 30° straight flared needle — D.O.R.C. Dutch Ophthalmic Research Center (International) B.V.
- 2.8 mm Disposable phaco set with 45° angled flared needle Note: Incision size 2. — D.O.R.C. Dutch Ophthalmic Research Center (International) B.V.
- 2.8 mm Reusable phaco set with 30° angled flared needle Note: Maximum 20x reusab — D.O.R.C. Dutch Ophthalmic Research Center (International) B.V.
- 2.8 mm Reusable phaco set with 30° straight flared needle — D.O.R.C. Dutch Ophthalmic Research Center (International) B.V.
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Unknown
MDR
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | MDR | — | Class II | Unknown |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
Sources (2)
- FDA UDI 253bcd6d-17db-425a-b67f-f42e030e7e4a 34 fields · synced Oct 8, 2026
- EUDAMED e1bccb11-9521-4b79-b969-c11f1d29f853 61 fields · synced Oct 8, 2026