Identity
- Trade Name
- Pergo EUDAMEDFDA UDI
- Generic Name
- Postsurgical eye shield, hermetic FDA UDI
- Device Name
- Eye Safety Tape EUDAMEDEye Safety Tape Pediatric FDA UDI
- Model / Reference
- 05TD0020 EUDAMEDFDA UDI
- Description
- Eye Safety Tape Pediatric FDA UDI
Identifiers
- Primary DI / UDI-DI
- 08681756010349 EUDAMEDFDA UDI
- Basic UDI-DI
- 8682952415563CX EUDAMED
- FDA Product Code
- HMP FDA UDI
- EMDN Code
- M040301 EYE PADS, COTTON OR NON-WOVEN MATERIALS EUDAMED
- GMDN Term
- Postsurgical eye shield, hermetic FDA UDI
Classification
- Device Class
- Class I EUDAMEDFDA UDI
- Regulation Number
- 878.4440 FDA UDI
- Market of Registration
- Austria 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
No
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
Yes
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
Yes
FDA UDI
Category: Postsurgical eye shield, hermetic
Pergo by Pergo Medikal Ve Ilac Sanayi Anonim Sirketi — Class I — MDR, FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS
Similar devices
Also classified as Postsurgical eye shield, hermetic.
- Bausch + Lomb — Bausch & Lomb Incorporated · Class I
- Pergo — PERGO MEDIKAL VE ILAC SANAYI ANONIM SIRKETI · Class I
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 I | Unknown |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- Pergo Medikal Ve Ilac Sanayi Anonim Sirketi
Sources (2)
- FDA UDI 96c9e8f0-bced-44b6-9cf8-2acd2aae28d3 33 fields · synced Oct 6, 2026
- EUDAMED 1f1d10ae-866d-462a-978b-4bd1fa2303bc 61 fields · synced Oct 6, 2026