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Novoglan Non Surgical Phimosis Treatment
EUDAMEDFDA UDIClass I (EU MDR)
Ref NFTE20221Model Standard
Identity
- Trade Name
- Novoglan Non Surgical Phimosis Treatment EUDAMEDNovoglan FDA UDI
- Generic Name
- Penile foreskin stretching kit FDA UDI
- Device Name
- Novoglan Foreskin Tissue Expander EUDAMEDA collection of devices intended to be operated by a patient at home to stretch the foreskin of the penis to treat phimosis (tightening of the foreskin) or to preferentially develop a looser foreskin. It consists of a balloon assembly, an inflator, cotton buds, insertion rods, and cleansing swabs. The inflatable balloon is inserted through the natural opening of the foreskin and positioned between the glans penis and the foreskin and inflated. This procedure is typically performed daily for a period (e.g., 14 days) to gradually stretch the foreskin. This is a single-patient device reapplied to the patient over a short term (single-use) before being discarded. FDA UDI
- Model / Reference
- Standard EUDAMEDNFTE20221 EUDAMEDFDA UDI
- Description
- A collection of devices intended to be operated by a patient at home to stretch the foreskin of the penis to treat phimosis (tightening of the foreskin) or to preferentially develop a looser foreskin. It consists of a balloon assembly, an inflator, cotton buds, insertion rods, and cleansing swabs. The inflatable balloon is inserted through the natural opening of the foreskin and positioned between the glans penis and the foreskin and inflated. This procedure is typically performed daily for a period (e.g., 14 days) to gradually stretch the foreskin. This is a single-patient device reapplied to the patient over a short term (single-use) before being discarded. FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00860009967205 EUDAMEDFDA UDI
- Basic UDI-DI
- 00860009967205GA EUDAMED
- EMDN Code
- P900199 TISSUE EXPANDERS - OTHER EUDAMED
- GMDN Term
- Penile foreskin stretching kit FDA UDI
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Ireland 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
Yes
FDA UDI
Convenience Kit
Yes
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
Yes
FDA UDI
Lot / Batch Number
No
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Novoglan Non Surgical Phimosis Treatment by Platigo Solutions Pty Limited — Class I — MDR, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Active
CE/MDR
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 00860009967205GA | Class I | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- Platigo Solutions Pty Limited
- EUDAMED SRN
- AU-MF-000029638
- Authorised Representative
- Wellkang Ltd XI-AR-000001836
Sources (2)
- EUDAMED 1ffcccae-9cf4-409c-b168-172bf4a356c9 61 fields · synced Jul 9, 2026
- FDA UDI ac2e0848-d623-406f-a16f-25175f3c36ae 33 fields · synced May 30, 2026